VENTAK AV AICD & VENTAK AV II DDD AICD
FDA premarket approval P960040/S010 · decided 1999-01-20
Approval details
- PMA number
- P960040
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VENTAK AV AICD & VENTAK AV II DDD AICD
- Applicant
- Boston Scientific
- Date received
- 1999-01-13
- Decision date
- 1999-01-20
- Days to decision
- 7 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for Software Application Model 2833 Version 3.1 for use with VENTAK(R) AV I/II(TM) DDD AICD(TM) Systems.
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