|
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 | S016 |
Date Received | 03/01/2019 |
Decision Date | 03/20/2019 |
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 Modifications to the manufacturing process for primary packaging. |