VENTAK AV DDD FAMILY OF AICD SYSTEMS
FDA premarket approval P960040/S004 · decided 1997-12-04
Approval details
- PMA number
- P960040
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VENTAK AV DDD FAMILY OF AICD SYSTEMS
- Applicant
- Boston Scientific
- Date received
- 1997-12-02
- Decision date
- 1997-12-04
- Days to decision
- 2 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for Software Application Model 2833 Version 3.0 which corrects a hardware limit anomaly.
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