|
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 | S063 |
Date Received | 08/10/2021 |
Decision Date | 09/09/2021 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for labeling changes which reduce risks and clearly explain how to use a newly designed accessory holder safely |