ST. JUDE MEDICAL MASTERS SERIES MECHANICAL HEART VALVE
FDA premarket approval P810002/S048 · decided 1999-04-16
Approval details
- PMA number
- P810002
- Supplement
- S048
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ST. JUDE MEDICAL MASTERS SERIES MECHANICAL HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- ABBOTT MEDICAL
- Date received
- 1998-11-04
- Decision date
- 1999-04-16
- Days to decision
- 163 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Approval for the addition of 35mm and 37mm mitral valve sizes to the SJM(R) Master Series Mechanical Heart Valve product line (SJM(TM) Master Series with Polyester Cuff, model number MJ-501, and SJM(R) Master Series with Silzone(TM) coating, Polyester Cuff, model number MS-601).
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