|
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 | S008 |
Date Received | 12/23/2010 |
Decision Date | 01/20/2011 |
Withdrawal Date
|
10/17/2022 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement EXPANSION OF THE TISSUE APPLICATION CONTROLLED ENVIRONMENT. |