|
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 | S062 |
Date Received | 03/04/2021 |
Decision Date | 01/13/2023 |
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 3rd tier sub-supplier change for the raw PTFE felt material used in the sewing ring of the devices. |