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 |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | CORCYM S.r.l. Via Crescentino, sn Saluggia 13040 |
PMA Number | P900060 |
Supplement Number | S022 |
Date Received | 01/22/2001 |
Decision Date | 02/16/2001 |
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 INCREASING THE STERILIZATION LOAD SIZE FOR CPHV(TM) AND UTILIZE MIXED LOADS OF CPHV(TM) AND ANNULOPLASTY RINGS (ANNULOFLO(R), AND/OR ANNULOFLEX(TM), TO MAXIMUM OF 384 BARRIERS IN THE SAME CYCLE AT TH EAUSTIN AND CALGARY FACILITIES. |
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