BILEAFLET-CENTER OPENING CARDIAC VALVE
FDA premarket approval P810002/S097 · decided 2016-04-27
Approval details
- PMA number
- P810002
- Supplement
- S097
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BILEAFLET-CENTER OPENING CARDIAC VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- ABBOTT MEDICAL
- Date received
- 2016-03-29
- Decision date
- 2016-04-27
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Shelf life extension of the conduit component of the SJM Masters Valved Graft.
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