VENTAK AV II DR AICD
FDA premarket approval P960040/S003 · decided 1998-03-13
Approval details
- PMA number
- P960040
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VENTAK AV II DR AICD
- Applicant
- Boston Scientific
- Date received
- 1997-11-04
- Decision date
- 1998-03-13
- Days to decision
- 129 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the VENTAK(R) AV(TM) II DR pulse generator Models 1821 and 1826, Model 2843 Application Software, Version 1.3 and revisions to the Physician's Manual, Package Labeling and Patient's Manual.
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