MASTERS SERIES VALVE: PTFE SEWING CUFF
FDA premarket approval P810002/S052 · decided 2000-06-30
Approval details
- PMA number
- P810002
- Supplement
- S052
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- MASTERS SERIES VALVE: PTFE SEWING CUFF
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- ABBOTT MEDICAL
- Date received
- 2000-05-22
- Decision date
- 2000-06-30
- Days to decision
- 39 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL TO REMOVE THE CONDITION OF APPROVAL IN THE JULY 23,1998 APPROVAL ORDER THAT THE FIRM PROVIDE RESULTS FROM TESTS WHICH DEMONSTRATE THE LONG-TERM INTEGRITY OF THE SEWING CUFF ATTACHMENT MECHANISM OF THE ST. JUDE MEDICAL(R) MASTER SERIES VALVE MODELS.
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