VENTAK P2 AICD MODEL 1625 & VENTAK P3 AICD MODELS 1630 AND 1635
FDA premarket approval P930035/S008 · decided 1997-12-15
Approval details
- PMA number
- P930035
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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
- 1997-09-30
- Decision date
- 1997-12-15
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the VENTAK(R) AV II pulse generator Models 1820 and 1825, Model 2833 Application Software, Version 2,8 and revised labeling to include shock energy as Joules "stored" rahter than Joules "delivered".
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