ST JUDE MEDICAL MECHANICAL HEART VALVE
FDA premarket approval P810002/S060 · decided 2007-11-21
Approval details
- PMA number
- P810002
- Supplement
- S060
- Supplement type
- 135 Review Track For 30-Day Notice
- 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
- 2006-10-23
- Decision date
- 2007-11-21
- Days to decision
- 394 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR A CHANGE TO THE SUPPLIER OF THE POLYESTER YARN THAT IS USED IN THE FABRICATION OF: 1) THE KNITTED POLYESTER TUBULAR FABRIC THAT IS THE SOURCE MATERIAL FROM THE ST. JUDE MEDICAL MECHANICAL HEART VALVE SEWING CUFFS, AND 2) THE HEMASHIELD BOVINE COLLAGEN SEALED WOVEN POLYESTER VASCULAR GRAFT.
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