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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, Perceval PLUS Sutureless Heart Valve
Generic Nameheart-valve, non-allograft tissue
ApplicantCorcym S.r.l.
Via Crescentino Sn
Saluggia 13040
PMA NumberP150011
Supplement NumberS030
Date Received10/31/2024
Decision Date01/24/2025
Product Code LWR 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for design changes related to the sutures and collar of the Perceval PLUS Sutureless Heart Valve, as well as manufacturing process changes. Manufacturing changes include the introduction of an automated laser cut process, introduction of a zero-pressure shaping process, and a change in the supplier of several suture threads.
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