MASTERS SERIES COATED AORTIC VALVED GRAFT(MODEL CAVGJ-514)
FDA premarket approval P810002/S049 · decided 1999-07-28
Approval details
- PMA number
- P810002
- Supplement
- S049
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MASTERS SERIES COATED AORTIC VALVED GRAFT(MODEL CAVGJ-514)
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- ABBOTT MEDICAL
- Date received
- 1999-02-09
- Decision date
- 1999-07-28
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Approval for the SJM(R) Master Series Aortic Valved Graft with Meadox(R) Hemashield(R) Woven Double Velour Graft, Model CAVGJ-514, in sizes 19, 21, 23, 25, 27, 29, 31, and 33 mm. This device is indicated for use when the aortic valve and the ascending aorta must be replaced.
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