VENTAK AV AICD TM SYSTEM
FDA premarket approval P960040/S002 · decided 1997-12-09
Approval details
- PMA number
- P960040
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VENTAK AV AICD TM SYSTEM
- Applicant
- Boston Scientific
- Date received
- 1997-09-30
- Decision date
- 1997-12-09
- Days to decision
- 70 days
- Decision code
- APPR
- 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" rather than Joules "delivered".
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