MECHANICAL HEART VALVE SJM(R) MASTER SERIES (EXPANDED SEWING CUFF)
FDA premarket approval P810002/S039 · decided 1996-03-21
Approval details
- PMA number
- P810002
- Supplement
- S039
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MECHANICAL HEART VALVE SJM(R) MASTER SERIES (EXPANDED SEWING CUFF)
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- ABBOTT MEDICAL
- Date received
- 1995-09-11
- Decision date
- 1996-03-21
- Days to decision
- 192 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR AN EXPANDED VERSION OF THE ST. JUDE MEDICAL MECHANICAL HEART VALVE WITH TEFLON SEWING CUFF. THE NEW MODELS WILL BE AVAILABLE IN THE AORTIC SIZES OF 19, 21, 23, 25, 27, 29, AND 31 MM (AET-104) AND THE MITRAL SIZES OF 19, 21, 23, 25, 27, 29, 31, AND 33MM (MET-104)
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