|
Device | Perceval Heart Valve |
Generic Name | heart-valve, non-allograft tissue |
Applicant | CORCYM Canada Corp. 5005 North Fraser Way Burnaby V5J 5 |
PMA Number | P150011 |
Supplement Number | S015 |
Date Received | 01/22/2019 |
Decision Date | 02/08/2019 |
Product Code |
LWR |
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 to instruct users on safe, future valve-in-valve implantations. |