CARBOMEDICS PROSTHETIC HEART VALVE, CARBO-SEAL ASCENDING AORTIC/ VALSALVA ASCENDING AORTIC PROSTHESIS
FDA premarket approval P900060/S035 · decided 2006-01-13
Approval details
- PMA number
- P900060
- Supplement
- S035
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CARBOMEDICS PROSTHETIC HEART VALVE, CARBO-SEAL ASCENDING AORTIC/ VALSALVA ASCENDING AORTIC PROSTHESIS
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Corcym S.r.l.
- Date received
- 2005-12-16
- Decision date
- 2006-01-13
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Saluggia
- Statement
- CHANGE IN THE FELTING PROCESS OF THE PTFE FELT FILTER.
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