VENTAK AV AICD FAMILY SYSTEMS
FDA premarket approval P960040/S007 · decided 1998-12-08
Approval details
- PMA number
- P960040
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VENTAK AV AICD FAMILY SYSTEMS
- Applicant
- Boston Scientific
- Date received
- 1998-11-25
- Decision date
- 1998-12-08
- Days to decision
- 13 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for revisions to the Physician's Manuals of the Ventak(R) AV(TM) AICD(TM) Systems.
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