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 | CARBOMEDICS CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESIS |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | CORCYM S.r.l. Via Crescentino, sn Saluggia 13040 |
PMA Number | P900060 |
Supplement Number | S024 |
Date Received | 06/11/2002 |
Decision Date | 12/10/2002 |
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 TO COMBINE THE CARBOMEDICS PROSTHETIC HEART VALVE (CPHV; APPROVED ON SEPTEMBER 29, 1993 UNDER P900060) WITH THE SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS (CLEARED ON JUNE 13, 2002 UNDER K013022). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CARBOMEDICS CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESIS, MODEL CP-(SIZE), WILL BE AVAILABLE IN SIZES 21, 23, 25, 27, 29, 31, AND 33 MM, 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 THE AORTA COMBINED WITH DISEASE OR DEGENERATION OF THE AORTIC VALVE. |
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