MECHANICAL HEART VALVE SJM(R) MASTER SERIES
FDA premarket approval P810002/S037 · decided 1995-08-11
Approval details
- PMA number
- P810002
- Supplement
- S037
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MECHANICAL HEART VALVE SJM(R) MASTER SERIES
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- ABBOTT MEDICAL
- Date received
- 1995-07-03
- Decision date
- 1995-08-11
- Days to decision
- 39 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR THE USE OF PROOF TESTING IN THE EVALUATION OF ST.JUNDE MEDICAL MECHANICAL HEART VALVES CONSTRUCTED WITH CARBOMEDICS, INC. MANUFACTURED COMPONENTS.
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