ST. JUDE MEDICAL MECHANICAL HEART VALVE
FDA premarket approval P810002/S045 · decided 1999-10-21
Approval details
- PMA number
- P810002
- Supplement
- S045
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ST. JUDE MEDICAL MECHANICAL HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- ABBOTT MEDICAL
- Date received
- 1997-05-05
- Decision date
- 1999-10-21
- Days to decision
- 899 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Approval for an increase of the orifice lot sizes during the pyrolytic carbon coating process at the Woodrige manufacturing facility.
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