Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP) |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | CORCYM S.r.l. Via Crescentino, sn Saluggia 13040 |
PMA Number | P900060 |
Supplement Number | S012 |
Date Received | 02/08/1996 |
Decision Date | 03/07/1997 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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 SIZES OF 21, 23, 25, 27, 29, 31, AND 33 MM. |
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