|
Device | CARBOMEDICS PROSTETIC HEART VALVE (CPHV) |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | CORCYM S.r.l. Via Crescentino, sn Saluggia 13040 |
PMA Number | P900060 |
Supplement Number | S030 |
Date Received | 01/27/2005 |
Decision Date | 04/08/2005 |
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 A CHANGE IN THE LOCK WIRE FABRICATION FOR THE CARBOMEDICS PROSTHETIC HEART VALVE. |