Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: MITROFLOW AORTIC PERICARDIAL HEART VALVE
• Generic Name: heart-valve, non-allograft tissue
• Applicant: Corcym Canada Corp; 5005 N. Fraser Way; Burnaby V5J 5M1
• PMA Number: P060038
• Supplement Number: S011
• Date Received: 02/21/2012
• Decision Date: 03/19/2012
• 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: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
CHANGE A CRITICAL COMPONENT SUPPLIER.