VENTAK(R) P3 AICD(TM) SYSTEM
FDA premarket approval P930035/S002 · decided 1995-05-25
Approval details
- PMA number
- P930035
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VENTAK(R) P3 AICD(TM) SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1995-03-30
- Decision date
- 1995-05-25
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
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