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 CALVE WITH PHOSPHOLIPID REDUCTION TREATMENT
• Generic Name: heart-valve, non-allograft tissue
• Applicant: Corcym Canada Corp; 5005 N. Fraser Way; Burnaby V5J 5M1
• PMA Number: P060038
• Supplement Number: S021
• Date Received: 09/22/2014
• Decision Date: 11/25/2014
• Withdrawal Date: 10/17/2022
• Product Code: LWR
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - OSB
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.