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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 PLUS Sutureless Heart Valve
Generic Nameheart-valve, non-allograft tissue
ApplicantCORCYM Canada Corp.
5005 North Fraser Way
Burnaby V5J 5
PMA NumberP150011
Supplement NumberS024
Date Received04/11/2022
Decision Date10/07/2022
Product Code LWR 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
approval for the Perceval RelyON PAK Accessories Kit for collapsing and releasing the Perceval PLUS valve and modification to the Instructions for Use to address the use of the new accessories.
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