BILEAFLET-CENTER OPENING CARDIAC VALVE
FDA premarket approval P810002/S009 · decided 1986-11-24
Approval details
- PMA number
- P810002
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BILEAFLET-CENTER OPENING CARDIAC VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- ABBOTT MEDICAL
- Date received
- 1986-07-23
- Decision date
- 1986-11-24
- Days to decision
- 124 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
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