CARBO-SEAL AND CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESES
FDA premarket approval P900060/S048 · decided 2012-03-07
Approval details
- PMA number
- P900060
- Supplement
- S048
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CARBO-SEAL AND CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESES
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Corcym S.r.l.
- Date received
- 2012-02-07
- Decision date
- 2012-03-07
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Saluggia
- Statement
- MODIFICATION TO THE LABELING ALGORITHM.
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