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 AND VALSALVA ASCENDING AORTIC PROSTHESIS |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | CORCYM S.r.l. Via Crescentino, sn Saluggia 13040 |
PMA Number | P900060 |
Supplement Number | S038 |
Date Received | 03/27/2007 |
Decision Date | 04/26/2007 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITIONAL STERILIZER FOR STERILIZING CARBOMEDICS CARBO-SEAL AND VALSALVA ASCENDING AORTIC PROSTHESIS DEVICES. |
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