|
Device | MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV) |
Generic Name | heart-valve, non-allograft tissue |
Applicant | CORCYM Canada Corp. 5005 North Fraser Way Burnaby V5J 5 |
PMA Number | P060038 |
Supplement Number | S012 |
Date Received | 04/12/2012 |
Decision Date | 10/09/2012 |
Withdrawal Date
|
10/17/2022 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE DEVICE. |