VENTAK P2 AICD MODEL 1625 & VENTAK P3 AICD MODELS 1630 AND 1635
FDA premarket approval P930035/S006 · decided 1996-12-11
Approval details
- PMA number
- P930035
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VENTAK P2 AICD MODEL 1625 & VENTAK P3 AICD MODELS 1630 AND 1635
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1996-09-05
- Decision date
- 1996-12-11
- Days to decision
- 97 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR PECTORAL PLACEMENT OF THE VENTAK(R) P3 PULSE GENERATOR
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