VENTAK P2 AICD MODEL 1625 & VENTAK P3 AICD MODELS 1630 AND 1635
FDA premarket approval P930035/S005 · decided 1996-05-15
Approval details
- PMA number
- P930035
- Supplement
- S005
- 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
- 1996-05-10
- Decision date
- 1996-05-15
- Days to decision
- 5 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- Yes
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE VENTAK P2 AICD MODEL 1625 AND THE VENTAK PC AICD MODELS 1630 AND 1635 WHICH REQUESTED APPROVAL TO ADD A PATIENT GROUP TO THE INDICATIONS FOR USE
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