VENTAK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS
FDA premarket approval P830060 · decided 1985-10-04
Approval details
- PMA number
- P830060
- Trade name
- VENTAK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1983-09-26
- Decision date
- 1985-10-04
- Days to decision
- 739 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the Automatic Implantable Cardioverter Defibrillator (AICD). The device is indicated for the treatment of ventricular tachycardia and ventricular fibrillation in those patients who are at high risk of sudden cardia death. Such patients are defined as (1) those who have survived at least one episode of cardiac arrest presumably due to hemodynamically unstable ventricular tachyarrhythmia not associated with acute myocardial infarction, and (2) those who, in the absence of such previou
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