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 PROSTHETIC HEART VALVE (CPHV) |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | CORCYM S.r.l. Via Crescentino, sn Saluggia 13040 |
PMA Number | P900060 |
Supplement Number | S013 |
Date Received | 02/27/1996 |
Decision Date | 08/27/1996 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE USE OF AN ALTERNATE CONTROLLED ENVIRONMENT FOR CPHV MANUFACTURING OPERATIONS. THE ALTERNATE CONTROLLED ENVIRONMENT WILL BE LOCATED WITHIN YOUR EXISTING MANUFACTURING FACILITY IN CALGARY, ALBERTA, CANADA |
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