|
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 | S014 |
Date Received | 12/10/2018 |
Decision Date | 01/08/2019 |
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 implemented to provide safety information regarding future valve in valve implantations. |