|
Device | Perceval Sutureless 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 | S013 |
Date Received | 05/01/2018 |
Decision Date | 10/16/2020 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01368666
|
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a new Perceval device model, the Perceval PLUS Sutureless Heart Valve, including a modification to the bovine pericardial tissue chemical treatment process and a reduction of the inflow ring height for the size XL valve. |