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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceMITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV)
Generic Nameheart-valve, non-allograft tissue
ApplicantCorcym Canada Corp
5005 N. Fraser Way
Burnaby V5J 5M1
PMA NumberP060038
Supplement NumberS024
Date Received09/22/2015
Decision Date11/24/2015
Withdrawal Date10/17/2022
Product Code LWR 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR REVISIONS TO THE MRI SAFETY LABELING.
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