|
Device | Perceval Sutureless Heart Valve and Perceval Plus 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 | S019 |
Date Received | 03/02/2020 |
Decision Date | 04/03/2020 |
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 Extend the maximum shipping time between abattoirs and the manufacturing site for bovine tissue from 48 hours to 96 hours. |