CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP)
FDA premarket approval P900060/S012 · decided 1997-03-07
Approval details
- PMA number
- P900060
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP)
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Corcym S.r.l.
- Date received
- 1996-02-08
- Decision date
- 1997-03-07
- Days to decision
- 393 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Saluggia
- Statement
- APPROVAL FOR A VALVED GRAFT VERSION OF THE CARBOMEDICS(R) PROSTHETIC HEART VALVE (CPHV). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CARBOMEDICS(R) CARBO-SEAL(TM) ASCENDING AORTIC PROSTHESIS (AAP) AND IS INDICATED FOR USE IN OPEN HEART SURGERY FOR SIMULTANEOUS REPLACEMENT OF THE ASCENDING AORTA AND THE AORTIC VALVE IN CASES OF ANEURYSM, DISSECTION, OR OTHER DISEASE CONDITIONS OF HTE AORTA COMBINED WITH DISEASE OR DEGENERATION OF THE AORTIC VALVE. THE DEVICE IS AVAILABLE IN THE
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