MASTERS SERIES COATED AORTIC VALVED GRAFT
FDA premarket approval P810002/S051 · decided 2000-05-05
Approval details
- PMA number
- P810002
- Supplement
- S051
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MASTERS SERIES COATED AORTIC VALVED GRAFT
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- ABBOTT MEDICAL
- Date received
- 2000-04-12
- Decision date
- 2000-05-05
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Approval for change to the method of forming the vascular graft taper and an increase in the sewing cuff fabric diameter per valve graft size.
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