|
Device | MITROFLOW AORTIC PERICARDIAL HEART VALVE |
Generic Name | heart-valve, non-allograft tissue |
Applicant | CORCYM Canada Corp. 5005 North Fraser Way Burnaby V5J 5 |
PMA Number | P060038 |
Supplement Number | S004 |
Date Received | 05/27/2009 |
Decision Date | 08/28/2009 |
Withdrawal Date
|
10/17/2022 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR THE ADDITION OF A NEW BOVINE PERICARDIUM SUPPLIER USED IN THE MANUFACTURE OF THE DEVICE. |