PMA P940024
- Device
- GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB.
- Applicant
- Telectronics Pacing Systems, Inc.
- PMA number
- P940024
- Product code
- LWS
- Decision date
- 1997-07-03
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR THE GUARDIAN(TM) ATP II MODEL 4211 IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR SYSTEM. THE GUARDIAN(TM) ATP II MODEL 4211 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR HEREAFTER REFERRED TO AS THE 4211 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM CONSISTS OF THE FOLLOWING: THE GUARDIAN(TM) ATP II MODEL 4211 IMPLANTABLE CARDIOVERTER DEFBRILLATOR; IMPLANTABLE DEFIBRILLATOR PATCH LEAD MODEL 040-105, 040-106, 040-107, 040-128, 040-129 AND 040-130; MODEL 4510 IMPLANT SUPPORT DEVICE; GENERIC 4211 PERSONALITY MODEULE; AND SYSTEM ACCESSORIES (ADAPTER MODELS 040-051, 040-052, 040-047, 040-055, 033-330, AND 033-320, MODEL 042-018 PATIENT INTERFACE MODULE, MODEL 040-021, STYLET KIT AND CABLE MODELS 042-010, 042-011, 042-015, 042-238 AND 042-017). THE 4211 SYSTEM IS INDICATED FOR USE IN PATIENTS WHO ARE AT HIGH RISK OF SUDDEN DEATH DUE TO VENTRICULAR FIBRILLATION AND/OR VENTRICULAR TACHYRHYTHMIAS AND WHO HAVE EXPERIENCED ONE OF THE FOLLOWING SITUATION: SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST (MANIFESTED BY A LOSS OF CONSCIOUSNESS) DUE TO VENTRICULAR TACHYRHYTHMIA OR RECURRENT, POORLY TOLERATED SUSTAINED VENTRICULAR TACHYCARDIA (VT). NOTE:THE CLINICAL OUTCOME FOR HEMODYNAMICALLY STABLE, SUSTAINED-VT PATIENTS IS NOT FULLY KNOWN. SAFETY AND EFFECTIVENESS STUDIES HAVE NOT BEEN CONDUCTED.
Current openFDA PMA Record#
- Device
- GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB.
- Applicant
- Telectronics Pacing Systems, Inc.
- PMA number
- P940024
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 1997-07-03
- Decision code
- APPR
- Date received
- 1994-07-08
- Approval order statement
- APPROVAL FOR THE GUARDIAN(TM) ATP II MODEL 4211 IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR SYSTEM. THE GUARDIAN(TM) ATP II MODEL 4211 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR HEREAFTER REFERRED TO AS THE 4211 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM CONSISTS OF THE FOLLOWING: THE GUARDIAN(TM) ATP II MODEL 4211 IMPLANTABLE CARDIOVERTER DEFBRILLATOR; IMPLANTABLE DEFIBRILLATOR PATCH LEAD MODEL 040-105, 040-106, 040-107, 040-128, 040-129 AND 040-130; MODEL 4510 IMPLANT SUPPORT DEVICE; GENERIC 4211 PERSONALITY MODEULE; AND SYSTEM ACCESSORIES (ADAPTER MODELS 040-051, 040-052, 040-047, 040-055, 033-330, AND 033-320, MODEL 042-018 PATIENT INTERFACE MODULE, MODEL 040-021, STYLET KIT AND CABLE MODELS 042-010, 042-011, 042-015, 042-238 AND 042-017). THE 4211 SYSTEM IS INDICATED FOR USE IN PATIENTS WHO ARE AT HIGH RISK OF SUDDEN DEATH DUE TO VENTRICULAR FIBRILLATION AND/OR VENTRICULAR TACHYRHYTHMIAS AND WHO HAVE EXPERIENCED ONE OF THE FOLLOWING SITUATION: SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST (MANIFESTED BY A LOSS OF CONSCIOUSNESS) DUE TO VENTRICULAR TACHYRHYTHMIA OR RECURRENT, POORLY TOLERATED SUSTAINED VENTRICULAR TACHYCARDIA (VT). NOTE:THE CLINICAL OUTCOME FOR HEMODYNAMICALLY STABLE, SUSTAINED-VT PATIENTS IS NOT FULLY KNOWN. SAFETY AND EFFECTIVENESS STUDIES HAVE NOT BEEN CONDUCTED.