VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM
FDA premarket approval P960040 · decided 1997-07-18
Approval details
- PMA number
- P960040
- Trade name
- VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1996-08-20
- Decision date
- 1997-07-18
- Days to decision
- 332 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE VENTAK(R) AV(TM) AICD(TM) MODEL 1810/MODEL 1815 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD(TM) WITH THE MODEL 2833 SOFTWARE APPLICATION. THIS DEVICE IS INDICATED FOR USE IN PATIENTS WHO ARE AT HIGH RISK OF SUDDEN CARDIAC DEATH DUE TO VENTRICULAR ARRHYTHMIAS AND WHO HAVE EXPERIENCED ONE OF THE FOLLOWING SITUATIONS: SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST (MANIFESTED BY THE LOSS OF CONSCIOUSNESS) DUE TO A VENTRICULAR TACHYARRHYTHMIA; RECURRENT, POORLY TOLERA
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