|
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 | S050 |
Date Received | 05/23/2012 |
Decision Date | 11/05/2012 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR ADDITION OF AN ALTERNATE SUPPLIER FOR MANUFACTURING OF THE GRAPHITE SUBSTRATE OF VALVE LEAFLETS. |