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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.
 
DevicePerceval Sutureless Heart Valve and Perceval Plus Sutureless Heart Valve
Generic Nameheart-valve, non-allograft tissue
ApplicantCORCYM Canada Corp.
5005 North Fraser Way
Burnaby V5J 5
PMA NumberP150011
Supplement NumberS020
Date Received03/16/2020
Decision Date06/11/2020
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
Approval Order Statement  
Approval for labeling changes related to sizing instructions for the Perceval Sutureless Heart Valve.
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