CARBOMEDICS CARBO-SEAL VALSALVA ASCENDING AORTIC PROTHESIS
FDA premarket approval P900060/S025 · decided 2003-08-01
Approval details
- PMA number
- P900060
- Supplement
- S025
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CARBOMEDICS CARBO-SEAL VALSALVA ASCENDING AORTIC PROTHESIS
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Corcym S.r.l.
- Date received
- 2003-05-13
- Decision date
- 2003-08-01
- Days to decision
- 80 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Saluggia
- Statement
- APPROVAL FOR AN EXTENSION OF SHELF LIFE FROM ONE TO FIVE YEARS FOR THE CARBOMEDICSCARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESIS (AAP).
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