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 PROTHESIS |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | CORCYM S.r.l. Via Crescentino, sn Saluggia 13040 |
PMA Number | P900060 |
Supplement Number | S025 |
Date Received | 05/13/2003 |
Decision Date | 08/01/2003 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN EXTENSION OF SHELF LIFE FROM ONE TO FIVE YEARS FOR THE CARBOMEDICSCARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESIS (AAP). |
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