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(R) PROSTHETIC HEART VALVE/CARBO-SEAL(R) ASCENDING AORTIC PROSTHESIS |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | CORCYM S.r.l. Via Crescentino, sn Saluggia 13040 |
PMA Number | P900060 |
Supplement Number | S021 |
Date Received | 08/07/2000 |
Decision Date | 09/05/2000 |
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 CHANGE TO A LARGER CAPACITY CHAMBER USED TO STERILIZE THE SULZER CARBOMEDICS CARBO-SEAL(R) ASCENDING AORTIC PROSTHESIS. THIS LARGER CAPACITY CHAMBER IS LOCATED AT THE FACILITY IDENTIFIED AS SULZER VASCUTEK LOCATED IN SCOTLAND. |
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