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Premarket Approval (PMA) Database

Premarket Approval (PMA) Database
Trade Name: DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR, PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number:
Date Received: 11-16-1995
Decision Date: 10-11-1996
Advisory Committee: CV
Supplement Type:
Product Code: DXY (Search Manufacturers)
Supplement Reason:
Approval Order Statement:
RATE ADAPTIVE PACING WITH THE DROMOS DR AND DROMOS SR PULSE GENERATORS IS INDICATED FOR PATIENTS EXHIBITING CHRONOTROPIC INCOMPETENCE AND WHO WOULD BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY
Trade Name: DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR, PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S001
Date Received: 03-31-1997
Decision Date: 03-13-1998
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK
Product Code: DXY (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COLOR ADDITIVE
Approval Order Statement:
Approval for a capacitive sensor, integrated circuit change and its supporting circuityr, hybrid circuit modification, battery change, pacemaker housing change, modified header, PMS 1000 C programmer, and the SWM 1000 F01.B00.U Software. The device, as modified, will be marketed under the trade name Actros Pacing System which consists of the following:Actros DR, D, SR, and S models, PMS 1000 C programmers, SWM 1000 (Version F01.B00.U). Rate adaptive pacing with the Actros DR and Actros SR pulse generators is indicated for patients exhibiting chronotropic incompetence and who would benefit from increase pacing rates concurrent with physical activity. Generally accepted indications for long-term cardiac pacing include, but not limited to:sick sinus syndrom (i.e., bradycardiatachcardia syndrome, sinus arrest, sinus bradycardia), sino-atrial (SA) block, second- and third- degree AV block, and carotid sinus syndrome. Patients who demonstrate hemodynamic benefit through maintenance of AV synchrony should be considered for one of te dual-chamber or atrial pacing modes. Dual-chamber modes are specfically indicated for treatment of conduction disorders that require both restoration of rate and AV synchrony such as AV nodal disease, diminished cardiac output or congestive heart failure associated with coduction distrurbances, and tachyarrhythmias that are suppressed by chronic pacing.
Trade Name: DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR, PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S002
Date Received: 07-06-1998
Decision Date: 08-13-1998
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: DXY (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER
Approval Order Statement:
Approval for the Scan Hysteresis feature, Repetitive Hysteresis feature, and Night Mode feature associated with the PMS 1000 C Programmer, and the SWM 1000 F03.B00.U Software. The device, as modified, will be marketed under the trade name Actros Pacing System which consists of the following: Actros DR, D, SR, and S models, PMS 1000 C programmers, SWM 1000 (Version F03.B00.U). Rate adaptive pacing with the Actros DR and Actros SR pulse generators is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with physical activity. Generally accepted indications for long-term cardiac pacing include, but not limited to:sick sinus syndrome (i.e., bradycardiatachcardia syndrome, sinus arrest, sinus bradycardia), sino-atrial (SA) block, second- and third- degree AV block, and carotid sinus syndrome. Patients who demonstrate hemodynamic benefit through maintenance of AV synchrony should be considered for one of the dual-chamber or atrial pacing modes. Dual-chamber modes are specifically indicated for treatment of conduction disorders that require both restoration of rate and AV synchrony such as AV nodal disease, diminished cardiac output or congestive heart failure associated with conduction disturbances, and tachyarrhythmias that are suppressed by chronic pacing.
Trade Name: ACTROS DR,D,SR, AND S PULSE GENERATORS AND PMS 1000C PROGRAMMING AND MONITORING SYSTEM
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR, PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S003
Date Received: 06-09-1998
Decision Date: 08-13-1998
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: DXY (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE
Approval Order Statement:
Approval for the Scan Hysteresis feature, Repetitive Hysteresis feature, and Night Mode feature associated with the PMS 1000 C programmer, and the SWM 1000 F03.B00.U Software. The device, as modified, will be marketed under the trade name Actros Pacing System which consists of the following: Actros DR, D, SR, and S models, PMS 1000 Cprogrammer, SWM 1000 (Version F03.B00.U). Rate adaptive pacing with the Actros DR and Actros SR pulse generators is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with physical activity. Generally accepted indications for long-term cardiac pacing include, but not limited to:sick sinus syndrom (i.e., bradycardiatachcardia syndrom, sinus arrest, sinus bradycardia), sino-atrial (SA) block, second- and third- degree AV block, and carotid sinus syndrome. Patients who demonstate hemodynamic benefit through maintenance of AV synchrony should be considered for one of the dual-chamber or atrial pacing modes. Dual-chamber modes are specifically indicated for treatment of conduction disorders that require both restoration of rate and AV synchrony such as AV nodal disease, diminished cardiac output or congestive heart failure associated with conduction disturbances, and tachyarrhythmias that are suppressed by chronic pacing.
Trade Name: ACTROS DR,D,SR, AND S PULSE GENERATORS AND PMS 1000C PROGRAMMING AND MONITORING SYSTEM
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR, PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S004
Date Received: 08-31-1998
Decision Date: 09-24-1998
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: DXY (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT
Approval Order Statement:
Approval for a slightly downsized header for the Actros DR, D, SR, and S pulse generators as well as approval for the Actros DR-A which is compatible with 5-mm leads and the Actros SR-B which is compatible with 6-mm leads. The device, as modified, will be marketed under the trade name Actros Pacing System which consists of the following: Actros DR, D, SR, S, DR-A, and SR-B models, PMS 1000 C programmers, SWM 1000 (Version F03.B00.U).
Trade Name: KAIROS
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR, PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S005
Date Received: 10-26-1998
Decision Date: 11-19-1998
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: DXY (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT
Approval Order Statement:
Approval for the Kairos family of pulse generators with B-G00.0.U Programmer Software for use with the Model 1000/1000C Programmers. As a discrete subset of the approved Actros family of pulse generators, the Kairos family is approved for the same indications.
Trade Name: ACTROS+
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S006
Date Received: 12-10-1998
Decision Date: 01-05-1999
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK
Product Code: DXY (Search Manufacturers)
Supplement Reason: LABELING CHANGE - TRADE NAME
Approval Order Statement:
Approval for a name change of the approved ACTROS Pulse Generator family to the ACTROS+ Pulse Generator family. The device, which has not been modified, will be marketed under the trade name ACTROS+ and is indicated for patients exhibiting chronotropic incompetence and who would benefit from increase pacing rates concurrent with physical activity. Generally accepted indications for long-term cardiac pacing inlcude, but are not limited to:sick sinus syndrom (i.e., bradycardia-tachycardia syndrome, sinus arrest, sinus bradycardia), sino-atrial(SA) block, second- and third- degree AV block and carotid sinus syndrome. Patients who demonstrate hemodynamic benefit through maintenance of AV synchrony should be considered for one of the dual-chamber or atrial pacing modes. Dual-chamber modes are specifically indicated for treatment of conduction disorders that require both resoration of rate and AV synchrony such as AV nodal disease, diminished cardiac output or congestive heart failure associated with conduction disturbances, and tachyarrhythmias that are suppressed by chronic pacing.
Trade Name: ACTROS SLR+,KAIROS SL PULSE GENERATORS;SL 60-11,13,15 BP SINGLE PASS PACING LEAD;SWM 1000 B-G01.0.U
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR; PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S007
Date Received: 01-20-1999
Decision Date: 08-04-1999
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK
Product Code: DXY (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT
Approval Order Statement:
Approval for a VDDR single pass lead system. The device is indicated for the following: The Actros SLR+ and Kairos SL pacemakers are intended to provide VDD or VDDR pacing for patients with a healthy sinus node and AV conduction abnormalities. These modes are indicated for patients who need ventricular pacing when adequate atrial rates and adequate intracavitary atrial complexes are present. this include the presence of complete A-v block when: 1) atrial contribution is needed for hemodynamic benefit; and 2) pacemaker syndrome had existed or is anticipated. Dual chamber modes are specifically indicated for treatment of conduction disorders that require both restoration or rate and AV synchrony such as AV nodal disease, diminished cardiac output, or congestive heart failure associated with conduction disturbances, and tachyarrhythmias that are suppressed by chronic pacing. Additional indications include: normal sinus rhythm and normal A-V conduction in patients who intermittently need ventricular pacing support.
Trade Name: ACTROS+ FAMILY OF PULSE GENERATORS
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR; PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S008
Date Received: 03-01-1999
Decision Date: 08-24-1999
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK
Product Code: DXY (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE
Approval Order Statement:
Approval for 1) Non-Invasive Programmed Stimulation (NIPS) feature to be unlocked; 2) Automatic Sensor Gain (ASG) feature to be allowed in Actros+ family; 3) Release of programmer software version B-H02.0.U; 4) Change of trade name of PMS 1000C programmer to EPR 1000PLUS; and 5) Use of the B-H02.0.U PCMIA software cartridge with TMS1000 Tachyarrhythmia Monitoring System (P980023) as well as use of the B-H02.0.U PCMIA software cartridge in the EPR 1000PLUS.
Trade Name: ACTROS DR+ -B PULSE GENERATOR
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR; PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S009
Date Received: 05-14-1999
Decision Date: 06-07-1999
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: DXY (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE
Approval Order Statement:
Approval for the B-H00.O.U Software module for use with the Biotronik PMS1000 series programmers, and the Actros DR+-B with dual 6mm header ports.
Trade Name: PHILOS PULSE GENERATOR
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR; PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S011
Date Received: 04-13-2000
Decision Date: 06-28-2000
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: DXY (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER
Approval Order Statement:
APPROVAL FOR THE USE OF A DIFFERENT SUBSTRATE MATERIAL (DYCOSTRATE(R).
Trade Name: PHILOS PULSE GENERATOR FAMILY AND SWM1000 B-K-00.0U SOFTWARE CARTRIDGE
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR; PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S012
Date Received: 05-15-2000
Decision Date: 06-22-2000
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: DXY (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT
Approval Order Statement:
APPROVAL FOR THE PHILOS PULSE GENERATOR FAMILY AND THE SWM1000 B-K00.0.U SOFTWARE CARTRIDGE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES PHILOS DR, PHILOS DR-B, PHILOS D, PHILOS SR, PHILOS SR-B, PHILOS S, PHILOS SLR, AND THE SWM1000 B-K00.0.U SOFTWARE CARTRIDGE.
Trade Name: ACTROS SLR PULSE GENERATOR
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR; PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S013
Date Received: 05-08-2000
Decision Date: 10-13-2000
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK
Product Code: DXY (Search Manufacturers)
Supplement Reason: LABELING CHANGE - MINOR
Approval Order Statement:
APPROVAL FOR REMOVAL OF THE WARNING LABEL WHICH RECOMMENDED PROGRAMMING DYNAMIC HYSTERESIS ON WHEN THE DEVICE IS PROGRAMMED TO THE VDDR MODE.
Trade Name: ACTROS FAMILY OF PULSE GENERATORS
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR; PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S014
Date Received: 05-30-2000
Decision Date: 06-20-2000
Advisory Committee: CV
Supplement Type: 30-DAY NOTICE
Product Code: DXY (Search Manufacturers)
Supplement Reason: PROCESS CHANGE: PACKAGING
Approval Order Statement:
CHANGE TO SMALLER BLISTER PACKAGING IN THE MANUFACTURING PROCESS OF ALL CURRENT AND FUTURE BIPOLAR PULSE GENERATOR FAMILIES.
Trade Name: PHILOS PULSE GENERATORS AND ASSOCIATED PROGRAMMER SOFTWARE.
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR; PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S015
Date Received: 08-07-2000
Decision Date: 09-05-2000
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: DXY (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE
Approval Order Statement:
APPROVAL FOR THE ACTIVATION OF THE PMT MANAGEMENT AND AV DELAY FEATURES IN THE PHILOS PULSE GENERATOR FAMILY, MODIFICATIONS TO THE PROGRAMMER SOFTWARE RESULTING IN VERSION B-K01.0.U, THE PGH 3000 PROGRAMMER HEAD, AND THE VK-92 PROGRAMMER PRINTER CABLE.
Trade Name: PHILOS FAMILY OF PULSE GENERATORS
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR; PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S016
Date Received: 10-06-2000
Decision Date: 10-31-2000
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: DXY (Search Manufacturers)
Supplement Reason: PROCESS CHANGE - OTHER
Approval Order Statement:
APPROVAL FOR THE USE OF ALTERNATIVE COMPONENTS IN THE PHILOS FAMILY OF PULSE GENERATORS, SPECIFICALLY: 1) THE LITRONIK GMBH AND CO. MODEL LIS 3150 BATTERY; AND 2) A LOW TEMPERATURE CO-FIRE CERAMIC (LTCC) SUBSTRATE.
Trade Name: ACTROS AND KAIROS FAMILY OF PULSE GENERATORS WITH LITRONIK BATTERY
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR; PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S017
Date Received: 09-27-2000
Decision Date: 05-24-2001
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK
Product Code: DXY (Search Manufacturers)
Supplement Reason: LOCATION CHANGE - OTHER
Approval Order Statement:
APPROVAL FOR THE USE OF THE LITRONIK BATTERY MODEL LIS 3150 IN THE ACTROS+ AND KAIROS PULSE GENERATOR FAMILIES.
Trade Name: PHILOS PACING SYSTEM
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR; PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S018
Date Received: 01-12-2001
Decision Date: 02-05-2001
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: DXY (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE
Approval Order Statement:
APPROVAL FOR PROGRAMMER SOFTWARE VERSION B-K02.V.U.
Trade Name: HOME MONITORING SYSTEM
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR;PROGRAMMER SOFTWARE
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S019
Date Received: 02-23-2001
Decision Date: 10-11-2001
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK
Product Code: DXY (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER
Approval Order Statement:
APPROVAL FOR MODIFICATIONS TO THE HARDWARE AND SOFTWARE, INCLUDING: 1) THE ADDITION OF A LOW-POWER, RADIOFREQUENCY (RF) TRANSMITTER TO THE IMPLANTABLE PULSE GENERATOR (IPG); 2) MODIFICATION OF THE IPG SOFTWARE TO PERMIT RF TRANSMISSION OF PATIENT AND DEVICE DATA FROM THE IPG; 3) THE ADDITION OF A CELL-PHONE-LIKE PATIENT DEVICE THAT RECEIVES RF DATA TRANSMITTED BY THE IPG THEN FORWARDS THE DATA TO ABIOTRONIK SERVICE CENTER VIA A CELLULAR TELEPHONE DIGITAL DATA TRANSMISSION SERVICE; AND 4) MODIFICATION OF THE PROGRAMMER SOFTWARE TO PERMIT PROGRAMMING OF THESE NEW IPG CAPABILITIES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HOME MONITORING SYSTEM, INCLUDING MODEL BA03 DDDR PULSE GENERATOR, MODEL RUC 200 PATIENT DEVICE, AND MODEL B-KT0.0.A PROGRAMMER SOFTWARE, AND IS INDICATED FOR PATIENTS WITH THE FOLLOWING CONDITIONS: RATE-ADAPTIVE PACING WITH THE BA03 DDDR PULSE GENERATORS IS INDICATED FOR PATIENTS EXHIBITING CHRONOTROPIC INCOMPETENCE AND WHO WOULD BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY. GENERALLY ACCEPTED INDICATIONS FOR LONG-TERM CARDIAC PACING INCLUDE, BUT ARE NOT LIMITED TO: SICK SINUS SYNDROME (I.E. BRADYCARDIA-TACHYCARDIA SYNDROME, SINUS ARREST, SINUS BRADYCARDIA), SINO-ATRIAL (SA) BLOCK, SECOND- AND THIRD- DEGREE AV BLOCK, AND CAROTID SINUS SYNDROME. PATIENTS WHOM DEMONSTRATE HEMODYNAMIC BENEFIT THROUGH MAINTENANCE OF AV SYNCHRONY SHOULD BE CONSIDERED FOR ONE OF THE DUAL-CHAMBER OR ATRIAL PACING MODES. DUAL-CHAMBER MODES ARE SPECIFICALLY INDICTED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE BOTH RESTORATION OF RATE AND AV SYNCHRONY SUCH AS AV NODAL DISEASE, DIMINISHED CARDIAC OUTPUT OR CONGESTIVE HEART FAILURE ASSOCIATED WITH CONDUCTION DISTURBANCES, AND TACHYARRHYTHMIAS THAT ARE SUPPRESSED BY CHRONIC PACING. ADDITIONAL INDICATIONS INCLUDE: NORMAL SINUS RHYTHM AND NORMAL A-V CONDUCTION IN PATIENTS WHO INTERMITTENTLY NEED VENTRICULAR PACING SUPPORT. NOTE: PATIENTS WITH KNOWN PAROXYSMAL ATRIAL...
Trade Name: BIOTRONIK INOS2+ CLS PULSE GENERATOR AND B-K05.V.U PROGRAMMER SOFTWARE
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR;PROGRAMMER SOFTWARE
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S020
Date Received: 06-11-2001
Decision Date: 10-10-2001
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK
Product Code: DXY (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT
Approval Order Statement:
APPROVAL FOR PULSE GENERATOR AND PROGRAMMER SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INOS2+ AND IS INDICATED FOR THE FOLLOWING APPLICATIONS: 1) RATE ADAPTIVE PACING WITH THE INOS PACING SYSTEM IS INDICATED FOR PATIENTS EXHIBITING CHRONOTROPIC INCOMPETENCE AND WHO WOULD BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY. 2) GENERALLY ACCEPTED INDICATIONS FOR LONG-TERM CARDIAC PACING INCLUDE, BUT ARE NOT LIMITED TO: SICK SINUS SYNDROME (I.E. BRADYCARDIA-TACHYCARDIA SYNDROME, SINUS ARREST, SINUS BRADYCARDIA), SINO-ATRIAL (SA) BLOCK, SECOND- AND THIRD- DEGREE AV BLOCK, AND CAROTID SINUS SYNDROME. 3) PATIENTS WHOM DEMONSTRATE HEMODYNAMIC BENEFIT THROUGH MAINTENANCE OF AV SYNCHRONY SHOULD BE CONSIDERED FOR ONE OF THE DUAL CHAMBER OR ATRIAL PACING MODES. DUAL CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE BOTH RESTORATION OF RATE AND AV SYNCHRONY SUCH AS AV NODAL DISEASE, DIMINISHED CARDIAC OUTPUT OR CONGESTIVE HEART FAILURE ASSOCIATED WITH CONDUCTION DISTURBANCES, AND TACHYARRHYTHMIAS THAT ARE SUPPRESSED BY CHRONIC PACING.
Trade Name: EDP 30 EXTERNAL DUAL CHAMBER PACEMAKER
Generic Name: EXTERNAL DUAL-CHAMBER PACEMAKER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S021
Date Received: 07-27-2001
Decision Date: 09-10-2001
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK
Product Code: DXY (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT
Approval Order Statement:
APPROVAL FOR THE EXTERNAL DUAL-CHAMBER PACEMAKER MODELS EDP 30. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EDP 30 AND IS INDICATED FOR: 1) TEMPORARY TREATMENT OF ARRHYTHMIAS AND HEART BLOCK; 2) PRE-, INTRA-, AND POSTOPERATIVE TEMPORARY STIMULATION OF PATIENTS UNDERGOING CARDIAC SURGERY; 3) PROPHYLACTIC PACING FOR PREVENTION OF ARRHYTHMIAS, AND 4) EMERGENCY PACING.
Trade Name: AXIOS PULSE GENERATOR FAMILY/B-K05.S.U PROGRAMMER SOFTWARE
Generic Name: EXTERNAL DUAL-CHAMBER PACEMAKER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S022
Date Received: 09-28-2001
Decision Date: 10-26-2001
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: DXY (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT
Approval Order Statement:
APPROVAL FOR THE AXIOS FAMILY OF PULSE GENERATORS AND THE B-K05.S.U PROGRAMMER SOFTWARE. THE AXIOS PULSE GENERATORS ARE INDICATED AS FOLLOWS: 1) RATE-ADAPTIVE PACING WITH AXIOS PULSE GENERATORS IS INDICATED FOR PATIENTS EXHIBITING CHRONOTROPIC INCOMPETENCE AND WHO WOULD BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY. 2) GENERALLY ACCEPTED INDICATIONS FOR LONG-TERM CARDIAC PACING INCLUDE, BUT ARE NOT LIMITED TO: SICK SINUS SYNDROME (I.E. BRADYCARDIA-TACHYCARDIA SYNDROME, SINUS ARREST, SINUS BRADYCARDIA), SINO-ATRIAL (SA) BLOCK, SECOND- AND THIRD- DEGREE AV BLOCK, AND CAROTID SINUS SYNDROME. 3) PATIENTS WHO DEMONSTRATE HEMODYNAMIC BENEFIT THROUGH MAINTENANCE OF AV SYNCHRONY SHOULD BE CONSIDERED FOR ONE OF THE DUAL CHAMBER OR ATRIAL PACING MODES. DUAL CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE BOTH RESTORATION OF RATE AND AV SYNCHRONY SUCH AS AV NODAL DISEASE, DIMINISHED CARDIAC OUTPUT OR CONGESTIVE HEART FAILURE ASSOCIATED WITH CONDUCTION DISTURBANCES, AND TACHYARRHYTHMIAS THAT ARE SUPPRESSED BY CHRONIC PACING.
Trade Name: PHILOS DR-T PULSE GENERATOR
Generic Name: EXTERNAL DUAL-CHAMBER PACEMAKER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S023
Date Received: 02-11-2002
Decision Date: 04-02-2002
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK
Product Code: DXY (Search Manufacturers)
Supplement Reason: DESIGN CHANGE - MINOR
Approval Order Statement:
APPROVAL FOR CHANGES TO THE PULSE GENERATOR TO ALLOW TRANSMISSION OF DIAGNOSTIC INFORMATION, AND FOR CHANGES TO THE PROGRAMMER SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PHILOS DR-T PULSE GENERATOR AND B-K00.T.U PROGRAMMER SOFTWARE, AND HAS THE SAME INDICATIONS AS THE CURRENTLY MARKETED PHILOS DR. SPECIFICALLY: 1) RATE ADAPTIVE PACING WITH PHILOS DR-T PULSE GENERATORS IS INDICATED FOR PATIENTS EXHIBITING CHRONOTROPIC INCOMPETENCE AND WHO WOULD BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY. 2) INDICATIONS FOR LONG-TERM CARDIAC PACING INCLUDE, BUT ARE NOT LIMITED TO: SICK SINUS SYNDROME (I.E., BRADYCARDIA-TACHYCARDIA SYNDROME, SINUS ARREST, SINUS BRADYCARDIA), SINO-ATRIAL (SA) BLOCK, SECOND- AND THIRD-DEGREE AV BLOCK, AND CAROTID SINUS SYNDROME. 3) PATIENTS WHO DEMONSTRATE HEMODYNAMIC BENEFIT THROUGH MAINTENANCE OF AV SYNCHRONY SHOULD BE CONSIDERED FOR ONE OF THE DUAL CHAMBER OR ATRIAL PACING MODES. DUAL CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE BOTH RESTORATION OF RATE AND AV SYNCHRONY SUCH AS AV NODAL DISEASE, DIMINISHED CARDIAC OUTPUT OR CONGESTIVE HEART FAILURE ASSOCIATED WITH CONDUCTION DISTURBANCES AND TACHYARRHYTHMIAS THAT ARE SUPPRESSED BY CHRONIC PACING.
Trade Name: SOLOX VDD PACING LEAD
Generic Name: EXTERNAL DUAL-CHAMBER PACEMAKER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S024
Date Received: 12-31-2001
Decision Date: 04-23-2003
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK
Product Code: DXY (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT
Approval Order Statement:
APPROVAL FOR THE SOLOX VDD PACING LEAD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SOLOX VDD PACING LEAD AND IS INDICATED AS FOLLOWS: THE SOLOX LEAD IS INDICATED FOR USE AS PART OF A SYSTEM ONLY. THE SYSTEM INCLUDES ANY OF BIOTRONIK'S VDD DUAL CHAMBER PULSE GENERATORS AND THE SOLOX VDD LEAD. THEREFORE, THE INDICATIONS FOR THE SOLOX VDD LEAD ARE IDENTICAL TO THE INDICATIONS FOR USE OF BIOTRONIK'S VDD DUAL CHAMBER PULSE GENERATORS. BIOTRONIK'S VDD DUAL CHAMBER PULSE GENERATORS ARE PRIMARILY INTENDED TO PROVIDE VDD PACING FOR PATIENTS WITH A HEALTHY SINUS NODE. THESE PULSE GENERATORS ARE SPECIFICALLY INDICATED FOR PATIENTS WHO NEED VENTRICULAR PACING WHEN ADEQUATE ATRIAL RATES ARE PRESENT. THIS INCLUDES THE PRESENCE OF COMPLETE A-V BLOCK WHEN: 1) ATRIAL CONTRIBUTION IS NEEDED FOR HEMODYNAMIC BENEFIT AND 2) PACEMAKER SYNDROME HAD EXISTED OR IS ANTICIPATED. ADDITIONAL INDICATIONS INCLUDE: NORMAL SINUS RHYTHM AND NORMAL A-V CONDUCTIONS IN PATIENTS WHO INTERMITTENTLY NEED VENTRICULAR PACING SUPPORT. NOTE: PATIENTS WITH KNOWN PAROXYSMAL ATRIAL FIBRILLATION/FLUTTER MAY REQUIRE FURTHER EVALUATION PRIOR TO IMPLANTATION. OTHER PACING MODES ARE INCORPORATE DIN THE PULSE GENERATOR (VDDR, VVI, VVIR, VOO, VOOR, VDT, VVT, AND VDI) IN ORDER TO PROVIDE CLINICAL FLEXIBILITY TO MANAGE CHANGES IN THE PATIENT'S CONDITION, FOR DIAGNOSTIC PURPOSES, OR IN THE EVENT THAT VDD PACING BECOMES INAPPROPRIATE.
Trade Name: PROTOS PULSE GENERATOR (PROTOS VR AND PROTOS DR) AND B-K00.P.U AND A-K00.0.U PROGRAMMER SOFTWARE
Generic Name: EXTERNAL DUAL-CHAMBER PACEMAKER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S028
Date Received: 11-15-2002
Decision Date: 12-06-2002
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: DXY (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT
Approval Order Statement:
APPROVAL FOR 1) THE COMBINATION OF ALL THE FEATURES OF THE PHILOS FAMILY WITH THE CLOSED LOOP STIMULATION (CLS METHOD OF RATE ADAPTIVE PACING; AND 2) THE ADDITION OF THE PROTOS APPLICATION TO THE SWM AND ATA PROGRAMMER SOFTWARE CARTRIDGES, THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROTOS VR AND PROTOS DR; AND SOFTWARE CARTRIDGES B-K00.P.U AND A-K00.0.U, AND IS INDICATED FOR: A) RATE ADAPTIVE PACING WITH THE PROTOS PACING SYSTEM IS INDICATED FOR PATIENTS EXHIBITING CHRONOTROPIC INCOMPETENCE AND WHO WOULD BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY. B) GENERALLY ACCEPTED INDICATIONS FOR LONG-TERM CARDIAC PACING INCLUDE, BUT ARE NOT LIMITED TO: SICK SINUS SYNDROME (I.E. BRADYCARDIA-TACHYCARDIA SYNDROME, SINUS ARREST, SINUS BRADYCARDIA), SINO-ATRIAL (SA) BLOCK, SECOND- AND THIRD-DEGREE AV BLOCK, AND CAROTID SINUS SYNDROME. C) PATIENTS WHO DEMONSTRATE HEMODYNAMIC BENEFIT THROUGH MAINTENANCE OF AV SYNCHRONY SHOULD BE CONSIDERED FOR ONE OF THE DUAL CHAMBER OR ATRIAL PACING MODES. DUAL CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE BOTH RESTORATION OF RATE AND AV SYNCHRONY SUCH AS AV NODAL DISEASE, DIMINISHED CARDIAC OUTPUT OR CONGESTIVE HEART FAILURE ASSOCIATED WITH CONDUCTION DISTURBANCES, AND TACHYARRHYTHMIAS THAT ARE SUPPRESSED BY CHRONIC PACING.
Trade Name: PROTOS FAMILY OF PULSE GENERATORS
Generic Name: EXTERNAL DUAL-CHAMBER PACEMAKER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S029
Date Received: 11-20-2002
Decision Date: 12-20-2002
Advisory Committee: CV
Supplement Type: 30-DAY NOTICE
Product Code: DXY (Search Manufacturers)
Supplement Reason: PROCESS CHANGE: MANUFACTURING
Approval Order Statement:
REDUCTION IN THE INCUBATION TIME OF THE BIOLOGICAL INDICATORS UTILIZED DURING THE STANDARD STERILIZATION PROCESS, FROM 7 DAYS TO 3 DAYS.
Trade Name: PHILOS DR ACC PACING SYSTEM AND PROGRAMMER SOFTWARE VERSION B-KAC.V.U/1
Generic Name: EXTERNAL DUAL-CHAMBER PACEMAKER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S030
Date Received: 01-09-2003
Decision Date: 08-04-2003
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK
Product Code: DXY (Search Manufacturers)
Supplement Reason: LABELING CHANGE - PERFORMANCE CHARACTERISTICS
Approval Order Statement:
APPROVAL FOR A MODIFIED PHILOS DR PACING SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PHILOS DR ACC PACING SYSTEM AND PROGRAMMER SOFTWARE VERSION B-KAC.V.U/1 AND IS INDICATED FOR USE IN PATIENTS WITH STANDARD BRADYCARDIA PACING INDICATIONS. RATE-ADAPTIVE PACING WITH THE PHILOS DR ACC PULSE GENERATOR IS INDICATED FOR PATIENTS EXHIBITING CHRONOTROPIC INCOMPETENCE AND WHO WOULD BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY. GENERALLY ACCEPTED INDICATIONS FOR LONG-TERM CARDIAC PACING INCLUDE, BUT ARE NOT LIMITED TO: SICK SINUS SYNDROME (I.E. BRADYCARDIA-TACHYCARDIA SYNDROME, SINUS ARREST, SINUS BRADYCARDIA), SINO-ATRIAL (SA) BLOCK, SECOND- AND THIRD- DEGREE AV BLOCK, AND CAROTID SINUS SYNDROME. PATIENTS WHO DEMONSTRATE HEMODYNAMIC BENEFIT THROUGH MAINTENANCE OF AV SYNCHRONY SHOULD BE CONSIDERED FOR ONE OF THE DUAL CHAMBER OR ATRIAL PACING MODES. DUAL CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE BOTH RESTORATION OF RATE AND AV SYNCHRONY SUCH AS AV NODAL DISEASE, DIMINISHED CARDIAC OUTPUT OR CONGESTIVE HEART FAILURE ASSOCIATED WITH CONDUCTION DISTURBANCES, AND TACHYARRHYTHMIAS THAT ARE SUPPRESSED BY CHRONIC PACING.
Trade Name: CARDIOMESSENGER HOME MONITORING SYSTEM
Generic Name: HOME MONITORING SYSTEM
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S031
Date Received: 02-06-2003
Decision Date: 02-25-2003
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: DXY (Search Manufacturers)
Supplement Reason: DESIGN CHANGE - MINOR
Approval Order Statement:
APPROVAL FOR OPTIMIZED CIRCUITRY, UPGRADED MODEM, UPGRADED BATTERY, AND AESTHETIC CHANGES.
Trade Name: PROTOS DR/CLS, PROTOS VR/CLS, AXIOS DR, AXIOS D, AXIOS S, AXIOS SR, AND AXIOS SLR PULSE GENERATORS WITH PROGRAMMER SOFT
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S032
Date Received: 02-28-2003
Decision Date: 03-31-2004
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK
Product Code: DTB (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE
Approval Order Statement:
APPROVAL FOR ADDING AXVX ADAPTIVE RATE PACING CAPABILITY TO THE PROTOS FAMILY OF PULSE GENERATORS, THE ADDITION OF THE DATA TRANSFER UTILITY SOFTWARE, AND MODIFICATIONS TO THE AXIOS FAMILY OF PULSE GENERATORS.
Trade Name: PHILOS DR-T PULSE GENERATOR/ICD BELOS VR-T,DR-T,ICD CARDIAC AIRBAG-T
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S033
Date Received: 06-24-2003
Decision Date: 12-17-2003
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK
Product Code: DXY (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE
Approval Order Statement:
APPROVAL FOR MODIFICATIONS TO HOME MONITORING THAT WILL ALLOW PHYSICIANS TO RECEIVE THE IMPLANT DATA VIA THE INTERNET, EMAIL, FAX OR MOBILE PHONE. HOME MONITORING MAY BE USED WITH THE FOLLOWING BIOTRONIK DEVICES: PHILOS DR-T, BELOS DR-T, BELOS VR-T, AND CARDIAC AIRBAG-T.
Trade Name: SELOX SR STEROID-ELUTING ACTIVE FIXATION ENDOCARDIAL PACING LEAD MODELS SR45, SR53, SR60 SR 53,SELOX SR 60
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S034
Date Received: 07-16-2003
Decision Date: 03-08-2004
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK
Product Code: DXY (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT
Approval Order Statement:
APPROVAL FOR ADDITION OF A DRUG COLLAR TO THE PACING LEAD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SELOX SR AND IS INDICATED AS FOLLOWING: BOTRONIK'S SELOX SR TRANSVENOUS, STEROID-ELUTING, ACTIVE FIXATION ENDOCARDIAL LEADS ARE INDICATED FOR PERMANENT PACING AND SENSING. ACTIVE FIXATION PACING LEADS WITH A BIPOLAR (BP) IS-1 CONNECTOR CONFIGURATION ARE DESIGNED FOR USE IN CONJUNCTION WITH IMPLANTABLE PULSE GENERATORS WITH IS-1 HEADERS. THE LEADS MAY BE USED WITH SINGLE OR DUAL CHAMBER PACING SYSTEMS. THE SELOX SR LEAD MODELS ARE INTENDED FOR PLACEMENT IN EITHER THE RIGHT ATRIUM OR RIGHT VENTRICLE.
Trade Name: IMPLANT CONTROL SYSTEM (ICS) 3000
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S035
Date Received: 07-28-2003
Decision Date: 05-18-2005
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK
Product Code: DXY (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - MATERIAL
Approval Order Statement:
APPROVAL FOR THE IMPLANT CONTROL SYSTEM (ICS) 3000 PACEMAKER PROGRAMMING SYSTEM, USING SOFTWARE VERSION 402.U.
Trade Name: PHILOS II DR, PHILOS II D, PHILOS II DR-T, PHILOS II SLR, PHILOS II SR, PHILOS II S, AND PROGRAMMER SOFTWARE VERSION A-U
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S036
Date Received: 11-04-2003
Decision Date: 03-31-2004
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK
Product Code: DXY (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER
Approval Order Statement:
APPROVAL FOR ADDITIONAL FEATURES ADDED TO THE PHILOS FAMILY OF PACEMAKERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PHILOS II AND IS INDICATED AS FOLLOWS: RATE-ADAPTIVE PACING WITH THE PHILOS II PULSE GENERATORS IS INDICATED FOR PATIENTS EXHIBITING CHRONOTROPIC INCOMPETENCE AND WHO WOULD BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY. GENERALLY ACCEPTED INDICATIONS FOR LONG-TERM CARDIAC PACING INCLUDE, BUT ARE NOT LIMITED TO: SICK SINUS SYNDROME (I.E. BRADYCARDIA-TACHYCARDIA SYNDROME, SINUS ARREST, SINUS BRADYCARDIA), SINO-ATRIAL (SA) BLOCK, SECOND- AND THIRD- DEGREE AV BLOCK, AND CAROTID SINUS SYNDROME. PATIENTS WHO DEMONSTRATE HEMODYNAMIC BENEFIT THROUGH MAINTENANCE OF AV SYNCHRONY SHOULD BE CONSIDERED FOR ONE OF THE DUAL CHAMBER OR ATRIAL PACING MODES. DUAL CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE BOTH RESTORATION OF RATE AND AV SYNCHRONY SUCH AS AV NODAL DISEASE, DIMINISHED CARDIAC OUTPUT OR CONGESTIVE HEART FAILURE ASSOCIATED WITH CONDUCTION DISTURBANCES, AND TACHYARRHYTHMIAS THAT ARE SUPPRESSED BY CHRONIC PACING. PHILOS II SLR PULSE GENERATORS ARE PRIMARILY INTENDED TO PROVIDE VDD OR VDDR PACING FOR PATIENTS WITH A HEALTHY SINUS NODE AND AV CONDUCTION ABNORMALITIES. THESE MODES ARE INDICATED FOR PATIENTS WHO NEED VENTRICULAR PACING WHEN ADEQUATE ATRIAL RATES AND ADEQUATE INTRACAVITARY ATRIAL COMPLEXES ARE PRESENT. THIS INCLUDES THE PRESENCE OF COMPLETE AV BLOCK WHEN: 1) ATRIAL CONTRIBUTION IS NEEDED FOR HEMODYNAMIC BENEFIT AND 2) PACEMAKER SYNDROME HAD EXISTED OR IS ANTICIPATED. ADDITIONAL INDICATIONS INCLUDE NORMAL SINUS RHYTHM AND NORMAL AV CONDUCTION IN PATIENTS WHO INTERMITTENTLY NEED VENTRICULAR PACING SUPPORT.
Trade Name: PHILOS DR-T PULSE GENERATOR AND A-K00.1.U/5 PROGRAMMER SOFTWARE
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S037
Date Received: 02-13-2004
Decision Date: 03-31-2004
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: DXY (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER
Approval Order Statement:
APPROVAL FOR THE ADDITION OF TWO CARDIO REPORT TRIGGERS FOR THE PHILOS DR-T PULSE GENERATOR AND FOR REVISIONS TO THE A-K00.1.U/5 PROGRAMMER SOFTWARE WHICH ARE NECESSARY IN ORDER TO UTILIZE THE MODIFIED PHILOS DR-T.
Trade Name: SELOX ST/JT STEROID-ELUTING PASSIVE-FIXATION ENDOCARDIAL PACKING LEAD MODELS SELOX ST 53, SELOX ST 60, SELOX JT 45 & 53
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S038
Date Received: 05-27-2004
Decision Date: 11-10-2004
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK
Product Code: DXY (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER
Approval Order Statement:
APPROVAL FOR THE ADDITION OF A DRUG COLLAR TO THE PACING LEAD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SELOX ST/JT AND IS INDICATED AS FOLLOWS: SELOX ST AND SELOX JT STEROID ELUTING LEADS ARE DESIGNED FOR USE WITH IMPLANTABLE PULSE GENERATORS THAT REQUIRE PACING LEADS WITH A BIPOLAR 3.2 MM IS-1 CONNECTOR CONFIGURATION; THEY MAY BE USED WITH SINGLE OR DUAL CHAMBER PACING SYSTEMS. THE LEADS ARE DESIGNED FOR USE IN PATIENTS FOR WHOM SINGLE OR DUAL CHAMBER PULSE GENERATOR THERAPY IS MEDICALLY INDICATED. THIS INDICATION FOLLOWS THAT RECOMMENDED IN THE CLASS I DEFINITION OF THE ACC/AHA/NASPE TASK FORCE REPORT, ENTITLED "ACC/AHA/NASPE 2002 GUIDELINE UPDATE FOR IMPLANTATION OF CARDIAC PACEMAKERS AND ANTIARRHYTHMIA DEVICES: A REPORT OF THE AMERICAN COLLEGE OF CARDIOLOGY/AMERICAN HEART ASSOCIATION TASK FORCE ON PRACTICE GUIDELINES (ACC/AHA/NASPE COMMITTEE ON PACEMAKER IMPLANTATION)" (GREGORATOS ET AL. 2002).
Trade Name: PROTOS DR/CLS AND PROTOS VR/CLS
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S039
Date Received: 08-09-2004
Decision Date: 06-22-2005
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK
Product Code: DXY (Search Manufacturers)
Supplement Reason: LABELING CHANGE - PERFORMANCE CHARACTERISTICS
Approval Order Statement:
APPROVAL FOR MODIFICATIONS TO THE LABELING.
Trade Name: CYLOS FAMILY OF PULSE GENERATORS
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S041
Date Received: 09-26-2005
Decision Date: 12-21-2005
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: DXY (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER
Approval Order Statement:
APPROVAL FOR THE CYLOS DR/DR-T AND CYLOS VR PULSE GENERATORS AND THE A-K00.6.U PROGRAMMER SOFTWARE (FOR USE WITH THE EPR 1000PLUS AND TMS 1000 PLUS PROGRAMMERS); THE 504.U PROGRAMMER SOFTWARE (FOR USE WITH THE ICS 3000 PROGRAMMER; AND THE HOME MONITORING SERVICE CENTER II VERSION 1.8.0.
Trade Name: SETROX S STEROID-ELUTING ACTIVE-FIXATION ENDOCARDIAL PACING LEAD (MODELS SETROX S 45, SETROX S 53, AND SETROX S 60)
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S042
Date Received: 11-10-2005
Decision Date: 02-14-2006
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK
Product Code: NVZ (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER
Approval Order Statement:
APPROVAL FOR MODIFICATIONS TO THE SELOX SR PACING LEAD FAMILY TO CHANGE THE STEROID DOSAGE, MAXIMUM LEAD BODY DIAMETER, AND RING ELECTRODE BASE MATERIAL, AS WELL AS OTHER MINOR CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SETROX S STEROID-ELUTING ACTIVE-FIXATION ENDOCARDIAL PACING LEAD AND IS INDICATED FOR PERMANENT PACING AND SENSING.
Trade Name: ACTROS, AXIOS, CYLOC, DROMOS, ERGOS, GEMNOS, KAIROS, KALOS, NANOS, NEOS, PHILOS, PHILOS II, PIKOS, PROTOS, TRIOS, BA03..
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S043
Date Received: 02-27-2006
Decision Date: 04-24-2006
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: NVZ (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT
Approval Order Statement:
APPROVAL FOR THE ICS 3000 WITH IMPLANT MODULE.
Trade Name: BIOTRONIK PACING AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S044
Date Received: 04-10-2006
Decision Date: 02-15-2007
Advisory Committee: CV
Supplement Type: 135 REVIEW TRACK FOR 30-DAY NOTICE
Product Code: NVZ (Search Manufacturers)
Supplement Reason: PROCESS CHANGE: PACKAGING
Approval Order Statement:
APPROVAL FOR CHANGES TO THE BLISTER PACKAGE AND OUTER SALES BOX.
Trade Name: VARIOUS MODELS OF PACEMAKERS ICS 3000/ EPR 1000 PLUS
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S045
Date Received: 06-29-2006
Decision Date: 07-26-2006
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: NVZ (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE
Approval Order Statement:
APPROVAL FOR PROGRAMMER SOFTWARE MODIFICATIONS (601.U AND A-K00.8.U) FOR USE IN BIOTRONIK PACEMAKERS AND IMPLANTABLE CARDIOVERTER DEFIBRILLATORS. THE MODIFICATIONS INCLUDED ADDING THE 1-OPT FEATURE, EXPANDING PROGRAMMER CAPABILITIES, IMPROVING PRINTING AND DATA IMPORT/EXPORT CAPABILITIES, ENHANCING COMMUNICATION AND MEMORY, UPDATING PROGRAMMABILITY AND RAM AND CORRECTING SOFTWARE ANOMALIES. THE SOFTWARE IS FOR USE WITH EPR 1000 PLUS PROGRAMMING SYSTEM, TMS 1000 PLUS PROGRAMMING SYSTEM AND ICS 3000 IMPLANT CONTROL SYSTEM.
Trade Name: LUMAX IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S046
Date Received: 09-12-2006
Decision Date: 12-07-2006
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK
Product Code: NVZ (Search Manufacturers)
Supplement Reason:
Approval Order Statement:
APPROVAL FOR THE LUMAX IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS), MODELS 300 VR, 340 VR, 300 VR-T, 340 VR-T, 300 DR, 340 DR, 300 DR-T, 340 DR-T, 300 HF, 340 HF, 300 HF-T AND 340 HF-T AND PROGRAMMER SOFTWARE VERSION 603.U FOR USE WITH THE LUMAX FAMILY OF ICDS AND BIOTRONIK, INC. PACERS, SINGLE CHAMBER ICDS AND DUAL CHAMBER ICDS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LUMAX, AND IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS AND/OR FOR PROVIDING TREATMENT OF CONGESTIVE HEART FAILURE.
Trade Name: SELECTED MODELS OF IPG BRADY CARDIA DEVICES
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S047
Date Received: 10-13-2006
Decision Date: 01-30-2007
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: NVZ (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT
Approval Order Statement:
APPROVAL FOR MINOR CHANGES TO THE RF CIRCUITRY IN THE LEXOS AND LUMOS FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND APPROVAL FOR UPDATED SOFTWARE VERSIONS TO CORRECT BRADYCARDIA AND TACHYCARDIA SOFTWARE ANOMALIES.
Trade Name: DEXTRUS STEROID-ELUTING ACTIVE FIXATION ENDOCARDIAL PACING LEADS MODELS 4135,4136 & 4137
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S048
Date Received: 12-13-2006
Decision Date: 03-08-2007
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: NVZ (Search Manufacturers)
Supplement Reason: DESIGN CHANGE - MINOR
Approval Order Statement:
APPROVAL FOR AN ADDITIONAL TRADE NAME FOR THE MARKET APPROVED SETROX S LEAD, AS WELL AS MINOR CHANGES TO THE ACCESSORIES, PACKAGING, AND LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEXTRUS, AND LABELED FOR DISTRIBUTION BY GUIDANT. THE DEXTRUS LEAD IS INDICATED FOR PERMANENT PACING AND SENSING IN EITHER THE RIGHT ATRIUM OR RIGHT VENTRICLE IN CONJUNCTION WITH IMPLANTABLE PULSE GENERATORS WITH IS-1 HEADERS.
Trade Name: VARIOUS MODELS OF PHILOS/AXIOS/PROTOS/CYLOS PG'S
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S049
Date Received: 01-12-2007
Decision Date: 03-26-2007
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: NVZ (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT
Approval Order Statement:
APPROVAL FOR: 1) UPDATES TO THE INTEGRATED CIRCUIT USED FOR ELECTROGRAM SENSING AND NON-RATE RESPONSIVE PACEMAKER TIMING, 2) MODIFICATIONS TO THE ELECTRONIC MODULE, AND 3) IMPLEMENTATION OF MULTI-LINGUAL LABELING.
Trade Name: PHILOS DR-T AND CYLOS DR-T
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S050
Date Received: 01-25-2007
Decision Date: 02-13-2007
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: NVZ (Search Manufacturers)
Supplement Reason: DESIGN CHANGE - MINOR
Approval Order Statement:
APPROVAL FOR MODIFICATIONS TO THE CARDIOMESSENGER AND CARDIOMESSENGER II USED WITH THE REFERENCED DEVICES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES: CARDIOMESSENGER TLINE AND CARDIOMESSENGER II LLT AND ARE INDICATED FOR TRANSMITTING DIAGNOSTIC PATIENT DATA FROM THE DEVICE TO THE PHYSICIAN.
Trade Name: PHILOS AND AXIOS FAMILY OF PULSE GENERATORS
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S051
Date Received: 04-10-2007
Decision Date: 08-31-2007
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: NVZ (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE
Approval Order Statement:
APPROVAL FOR CHANGES TO THE INTEGRATED CIRCUIT PACKAGING, CIRCUIT BOARD SUBSTRATE, HEADER ASSEMBLY, AND THE TEL 3000 INTERFACE IN THE PHILOS AND AXIOS FAMILY OF PULSE GENERATORS.
Trade Name: PHILOS FAMILY OF PULSE GENERATORS
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S052
Date Received: 06-25-2007
Decision Date: 07-25-2007
Advisory Committee: CV
Supplement Type: 30-DAY NOTICE
Product Code: NVZ (Search Manufacturers)
Supplement Reason: PROCESS CHANGE: MANUFACTURING
Approval Order Statement:
CHANGE WHERE THE CABLES ARE PACKAGED.
Trade Name: CYLOS PACEMAKER & PHILOS II PACEMAKERS & ICS 3000 IMPLANT CONTROL SYSTEM & IMPLANT MODULE
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S053
Date Received: 07-13-2007
Decision Date: 12-07-2007
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK
Product Code: NVZ (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE
Approval Order Statement:
APPROVAL FOR THE APPLICATION SOFTWARE VERSION A-K00.10U OF THE PMS/TMS 1000, AND APPLICATION SOFTWARE VERSION 703.U/1 OF THE ICS 3000.
Trade Name: CARDIOMESSENGER II
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S054
Date Received: 08-13-2007
Decision Date: 11-09-2007
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK
Product Code: NVZ (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - MATERIAL
Approval Order Statement:
APPROVAL FOR SOFTWARE, HARDWARE, PACKAGING AND LABELING MODIFICATIONS TO THE DEVICES.
Trade Name: ICS 3000 IMPLANT CONTROL SYSTEM
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S055
Date Received: 10-25-2007
Decision Date: 12-07-2007
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: NVZ (Search Manufacturers)
Supplement Reason: DESIGN CHANGE - MINOR
Approval Order Statement:
APPROVAL FOR CHANGES TO THE ICS 300 PROGRAMMER HEAD, TECHNICAL MANUAL, AND THE PGH BLUE FOIL LABEL.
Trade Name: SELOX ST/JT, SETROX S & DEXTRUS
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S056
Date Received: 01-07-2008
Decision Date: 02-29-2008
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: NVZ (Search Manufacturers)
Supplement Reason: DESIGN CHANGE - MINOR
Approval Order Statement:
APPROVAL FOR LEAD SUTURE SLEEVE DESIGN CHANGES, DOWNSIZED PACEMAKER SHIPPING BOXES, AND USE OF NON-LINGUAL SYMBOLS ON PACEMAKER LABELING.
Trade Name: VARIOUS MODELS OF PHILOS/PHILOS, AXIOS, PROTOS PULSE GENERATOR
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S057
Date Received: 02-05-2008
Decision Date: 07-11-2008
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK
Product Code: NVZ (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT
Approval Order Statement:
APPROVAL FOR A LARGER OI-CIRCUIT CAPACITOR AND MODIFICATION TO THE CERAMIC FEEDTHROUGH.
Trade Name: CYLOS DR, PROTOS DR-CLS, PHILOS 2 DR, PHILOS DR, AXIOS DR
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S058
Date Received: 03-18-2008
Decision Date: 04-11-2008
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: NVZ (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER
Approval Order Statement:
APPROVAL FOR AN ALTERNATIVE SOURCE OF THE LITHIUM TO BE USED IN THE DEVICE.
Trade Name: ACTROS, AXIOS, BA03, CYLOS, DROMOS, KAIROS, PHILOS, PHILOS II, AND PROTOS FAMILIES OF PULSE GENERATORS
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S059
Date Received: 05-15-2008
Decision Date: 11-04-2008
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK
Product Code: NVZ (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SPECIFICATIONS
Approval Order Statement:
APPROVAL FOR THE ADDITION OF MODELS 500/540 TO THE LUMAX FAMILY OF ICD/CRT-DS AND ICS 3000 PROGRAMMER. THESE MODELS WOULD CONTAIN: ¿ A THIRD PROGRAMMABLE CARDIOVERSION / DEFIBRILLATION SHOCK PATHWAY TO OFFER MORE PROGRAMMING OPTIONS ¿ AUTOMATIC THRESHOLD MEASUREMENT (ATM) FEATURE ¿ ELECTRONIC MODULE (HARDWARE) UPDATES TO SUPPORT THE THIRD PROGRAMMABLE SHOCK PATH ¿ MODIFICATIONS TO THE LITRONIK BATTERIES TO INCREASE CAPACITY ¿ NEW STANDARD VALUE OF THE PROGRAMMABLE PACING PULSE WIDTH ¿ UPDATED RAM FIRMWARE TO SUPPORT NEW FEATURES
Trade Name: DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEM
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S060
Date Received: 05-15-2008
Decision Date: 06-02-2008
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: NVZ (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE
Approval Order Statement:
APPROVAL FOR PROGRAMMER SOFTWARE VERSION 801.U.
Trade Name: DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S061
Date Received: 05-21-2008
Decision Date: 06-09-2008
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: NVZ (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE
Approval Order Statement:
APPROVAL FOR MINOR MECHANICAL CHANGES TO THE ICS 3000 PROGRAMMER INCLUDING REMOVAL OF MAGNETS FROM THE PGH WAND AND REPLACEMENT OF AN EXISTING CONNECTOR AS WELL AS ASSOCIATED LABELING UPDATES.
Trade Name: CYLOS/PROTOS/AXIOS/PHILOS II & PHILOS/PHILOS DR-T PULSE GENERATORS
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S063
Date Received: 12-03-2008
Decision Date: 12-31-2008
Advisory Committee: CV
Supplement Type: 30-DAY NOTICE
Product Code: NVZ (Search Manufacturers)
Supplement Reason: PROCESS CHANGE: MANUFACTURING
Approval Order Statement:
CHANGE IN THE COMPONENT SUPPLIER FOR THE BATTERY CATHODE.
Trade Name: CYLOS DR-T PULSE GENERATOR
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S064
Date Received: 10-20-2008
Decision Date: 11-24-2008
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: NVZ (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT
Approval Order Statement:
APPROVAL FOR MODIFICATIONS TO THE HEADER ASSEMBLY AND A CORRECTION TO THE TECHNICAL MANUAL.
Trade Name: PHILOS II FAMILY OF PULSE GENERATORS
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S065
Date Received: 10-20-2008
Decision Date: 11-06-2008
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: NVZ (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT
Approval Order Statement:
APPROVAL FOR MODIFICATIONS TO THE INTEGRATED CIRCUITS, HEADER AND CAN OF THE PHILOS II FAMILY OF PULSE GENERATORS.
Trade Name: PHILOS II FAMILY OF PULSE GENERATORS
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S066
Date Received: 11-04-2008
Decision Date: 11-21-2008
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: NVZ (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT
Approval Order Statement:
APPROVAL FOR UPDATES TO THE HOME MONITORING SERVICE CENTER USED WITH THE PHILOS II AND CYLOS FAMILIES OF PULSE GENERATORS LEXOS AND LUMOS FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS. STRATOS LV-T PULSE GENERATOR. CARDIAC AIRBAG-T AND BELOS VR-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, AND THE KRONOS LV-T AND LUMAX FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.
Trade Name: PROGRAMMER SOFTWARE (ICS 3000 802.U/2)
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S067
Date Received: 11-19-2008
Decision Date: 03-31-2009
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK
Product Code: NVZ (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE
Approval Order Statement:
APPROVAL FOR: 1) COMMERCIAL DISTRIBUTION OF THE LUMAX HF-T CRT-DS AND STRATOS LV (-T) CRT-PS WITH VENTRICLE TO VENTRICLE (V-V) DELAY FEATURES; AND 2) UPDATED MODEL ICS 3000 PROGRAMMER SOFTWARE (RELEASE OF 802.U/2) TO IMPLEMENT THE V-V DELAY FEATURES AND OTHER MINOR ENHANCEMENTS.
Trade Name: PHILOS II DR-T
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S068
Date Received: 01-26-2009
Decision Date: 05-12-2009
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK
Product Code: NVZ (Search Manufacturers)
Supplement Reason: LABELING CHANGE - INSTRUCTIONS
Approval Order Statement:
APPROVAL FOR MODIFICATION OF PRODUCT LABELING FOR DEVICES THAT UTILIZE HOME MONITORING. SPECIFICALLY, SUPPLEMENTS REQUESTED APPROVAL FOR THE REPLACEMENT OF EXISTING PRECAUTIONS AND THE FOLLOWING MARKETING STATEMENTS: 1) BIOTRONIC HOME MONITORING INFORMATION MAY BE USED AS A REPLACEMENT FOR DEVICE INTERROGATION DURING IN-OFFICE FOLLOW-UP VISITS. 2) A STRATEGY OF CARE USING BIOTRONIK HOME MONITORING WITH OFFICE VISITS WHEN NEEDED - HAS BEEN SHOWN TO EXTEND THE LIME BETWEEN ROUTINE, SCHEDULED IN-OFFICE FOLLOW-UPS OF BIOTRONIK IMPLANTABLE DEVICES IN MANY PATIENTS. HOME MONITORING DATA IS HELPFUL IN DETERMINING THE NEED FOR ADDITIONAL IN-OFFICE FOLLOW-UP. 3) BIOTRONIK HOME MONITORING PATIENTS -WHO ARE FOLLOWED REMOTELY WITH OFFICE VISITS WHEN NEEDED - HAVE BEEN SHOWN TO HAVE SIMILAR NUMBERS OF STROKES, INVASIVE PROCEDURES AND DEATHS AS PATIENTS FOLLOWED WITH CONVENTIONAL IN-OFFICE FOLLOW-UPS. 4) BIOTRONIK HOME MONITORING PROVIDES EARLY DETECTION OF ARRHYTHMIAS. 5) BIOTRONIK HOME MONITORING PROVIDES EARLY DETECTION OF SILENT, ASYMPTOMATIC ARRHYTHMIAS. 6) AUTOMATIC EARLY DETECTION OF ARRHYTHMIAS AND DEVICE SYSTEM ANOMALIES BY BIOTRONIK HOME MONITORING ALLOWS FOR EARLIER INTERVENTION THAN CONVENTIONAL IN-OFFICE FOLLOW-UPS. 7) BIOTRONIK HOME MONITORING ALLOWS FOR IMPROVED ACCESS TO PATIENT DEVICE DATA COMPARED TO CONVENTIONAL IN-OFFICE FOLLOW-UPS SINCE DEVICE INTERROGATION IS AUTOMATICALLY SCHEDULED AT REGULAR INTERVALS.
Trade Name: PHILOS DR-T, PHILOSII DR-T AND CYLOS DR-T
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S069
Date Received: 02-13-2009
Decision Date: 03-23-2009
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: NVZ (Search Manufacturers)
Supplement Reason: PROCESS CHANGE - OTHER
Approval Order Statement:
APPROVAL FOR AND UPDATE TO THE BIOTRONIK HOME MONITORING SERVICE CENTER TO VERSION 3.2.
Trade Name: ICS 3000/EDP 30/CARDIOMESSENGER
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S070
Date Received: 03-06-2009
Decision Date: 04-03-2009
Advisory Committee: CV
Supplement Type: 30-DAY NOTICE
Product Code: NVZ (Search Manufacturers)
Supplement Reason: PROCESS CHANGE: MANUFACTURING
Approval Order Statement:
CHANGE IN MANUFACTURING LOCATION FOR EXTERNAL DEVICES TO ANOTHER LOCATION IN BERLIN, GERMANY.
Trade Name: PULSE GENERATORS PHILOS II DR-T/CYLOS DR-T
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S071
Date Received: 03-23-2009
Decision Date: 04-16-2009
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: NVZ (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE
Approval Order Statement:
APPROVAL FOR THE REMOVAL OF THE DIAL-IN PREFIXES IN THE DEVICE.
Trade Name: EVIA / ENTOVIS & VARIOUS OTHER PULSE GENERATORS
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S072
Date Received: 07-08-2009
Decision Date: 05-07-2010
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK
Product Code: NVZ (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT
Approval Order Statement:
APPROVAL FOR THE EVIA/ENTOVIS PULSE GENERATORS.
Trade Name: HOME MONITORING SERVICE CENTER 3 - VERSION 3.6
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S073
Date Received: 09-10-2009
Decision Date: 10-22-2009
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: NVZ (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT
Approval Order Statement:
APPROVAL FOR VERSION 3.6 OF THE HOME MONITORING SERVICE CENTER 3.
Trade Name: ACTROS, AXIOS, KAIROS, CYLOS, DROMOS, PHILOS, AND PHILOS II FAMILIES OF PACEMAKER PULSE GENERATORS AND PROGRAMMERS
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S074
Date Received: 11-24-2009
Decision Date: 01-22-2010
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: NVZ (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT
Approval Order Statement:
APPROVAL TO IMPLEMENT HARDWARE CHANGES TO THE ICS 3000 IMPLANT CONTROL SYSTEM.
Trade Name: ACTROS & AXIOS & KAIROS DR/SR/SLR/D/S/BA03 DDDR/CYLOS DR/DR-T/VR/DOMOS DR/SR/SL/PHILOS&PHILOS II DR/DR-T/SR/SLR/D/S/PROT
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S076
Date Received: 11-25-2009
Decision Date: 01-22-2010
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: NVZ (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE
Approval Order Statement:
APPROVAL FOR A SOFTWARE UPGRADE TO VERSION 902.U/1. THIS SOFTWARE IS USED IN THE ICS 3000 SYSTEM TO PROGRAM AND INTERROGATE ALL OF BIOTRONIK¿S US MARKET RELEASED BRADYCARDIA AND TACHYCARDIA PACEMAKERS.
Trade Name: SETROX S & DEXTRUS LEADS
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S077
Date Received: 02-12-2010
Decision Date: 03-12-2010
Advisory Committee: CV
Supplement Type: 30-DAY NOTICE
Product Code: NVZ (Search Manufacturers)
Supplement Reason: PROCESS CHANGE: MANUFACTURING
Approval Order Statement:
ADDITION OF ALTERNATE SUPPLIERS FOR LEAD SPRING AND EXTERNAL SLEEVE.
Trade Name: LUMAX 540 VR-T DX ICDS
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S078
Date Received: 03-02-2010
Decision Date: 04-30-2010
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: NVZ (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER
Approval Order Statement:
APPROVAL FOR INTRODUCTION OF THE LUMAX 540 VR-T DX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), A SINGLE LEAD ICD SYSTEM USED IN CONJUNCTION WITH THE CURRENTLY APPROVED KAINOX A+ ICD LEAD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LUMAX 540 VR-T DX ICD AND IS INDICATED FOR PROVIDING VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION, FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.
Trade Name: RELIATY/MODEL 3145 PACING SYSTEM ANALYZER
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S079
Date Received: 03-23-2010
Decision Date: 09-02-2010
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK
Product Code: NVZ (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT
Approval Order Statement:
APPROVAL FOR A STAND-ALONE VERSION OF THE PACING SYSTEM ANALYZER FUNCTION FOUND IN THE ICS 3000 IMPLANT CONTROL SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RELIATY BY BIOTRONIK, INC. AND MODEL 3145 BY BOSTON SCIENTIFIC AND IS INDICATED FOR USE IN PACING LEAD SYSTEM ANALYSIS DURING THE IMPLANTATION OF PACEMAKERS AND DEFIBRILLATORS.
Trade Name: STEROX S AND DEXTRUS FAMILY OF IMPLANTABLE PACEMAKER PULSE GENERATORS AND PROGRAMMERS
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S080
Date Received: 04-13-2010
Decision Date: 05-13-2010
Advisory Committee: CV
Supplement Type: 30-DAY NOTICE
Product Code: NVZ (Search Manufacturers)
Supplement Reason: PROCESS CHANGE: PACKAGING
Approval Order Statement:
CHANGE IN PACKAGING TO THE INNER AND OUTER BAGS OF THE STERILIZED STYLET ACCESSORIES.
Trade Name: CARDIOMESSENGER-S AND CARDIOMESSENGER-S TLINE
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S081
Date Received: 05-12-2010
Decision Date: 06-18-2010
Advisory Committee: CV
Supplement Type: REAL-TIME PROCESS
Product Code: NVZ (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT
Approval Order Statement:
APPROVAL FOR THE CARDIOMESSENGER-S AND CARDIOMESSENGER-S TLINE.
Trade Name: EVIA/ENTOVIS & VARIOUS MODELS OF PHILOS/PHILOS2 & CYLOS PULSE GENERATORS; SELOX JT/ST/SR, DEXTRUS, SELTROX S, SLX
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S082
Date Received: 05-28-2010
Decision Date: 07-30-2010
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK NO USER FEE
Product Code: NVZ (Search Manufacturers)
Supplement Reason: LOCATION CHANGE: STERILIZER
Approval Order Statement:
APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS GERMANY GMBH, WIESBADEN, GERMANY AS AN ALTERNATE STERILIZATION FACILITY.
Trade Name: EVIA/ENTOVIS DR/DR-T/SR-T & VARIOUS OTHER MODELS OF PULSE GENERATORS
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S083
Date Received: 06-08-2010
Decision Date: 11-26-2010
Advisory Committee: CV
Supplement Type: NORMAL 180 DAY TRACK
Product Code: NVZ (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE
Approval Order Statement:
CHANGE IN THE USB CABLE ASSEMBLY, AS WELL AS THE SUPPLIER FOR THE CABLE, TO BE USED WITH THE ESTEEM PROGRAMMER.
Trade Name: PHILOS DR/SR & PHILOS II DR/SR
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S085
Date Received: 08-12-2010
Decision Date: 09-10-2010
Advisory Committee: CV
Supplement Type: 30-DAY NOTICE
Product Code: NVZ (Search Manufacturers)
Supplement Reason: PROCESS CHANGE: MANUFACTURING
Approval Order Statement:
ALTERNATE JOINING PROCESS OF PULSE GENERATOR HOUSINGS.
Trade Name: PHILOS DR/SR/PHILOS II DR /SR/CYLOS DR/DR-T/VR/EVIA DR/DR-T/ENTOVIS DR PULSE GENERATORS
Generic Name: IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMER
Applicant: BIOTRONIK, INC.
PMA Number: P950037
Supplement Number: S086
Date Received: 08-20-2010
Decision Date: 09-17-2010
Advisory Committee: CV
Supplement Type: 30-DAY NOTICE
Product Code: NVZ (Search Manufacturers)
Supplement Reason: PROCESS CHANGE - OTHER
Approval Order Statement:
NEW LABELING SOFTWARE USED TO PRINT THE LABELS FOR VARIOUS DEVICES AND ACCESSORIES.
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