VENTAK AV DDD FAMILY OF AICD SYSTEMS
FDA premarket approval P960040/S005 · decided 1998-02-02
Approval details
- PMA number
- P960040
- Supplement
- S005
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VENTAK AV DDD FAMILY OF AICD SYSTEMS
- Applicant
- Boston Scientific
- Date received
- 1998-01-22
- Decision date
- 1998-02-02
- Days to decision
- 11 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for changes in the VENTAK(R) AV II Physician's Manual and Device Warranty.
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