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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
Generic Nameheart-valve, non-allograft tissue
ApplicantCorcym S.r.l.
Via Crescentino Sn
Saluggia 13040
PMA NumberP150011
Supplement NumberS013
Date Received05/01/2018
Decision Date10/16/2020
Product Code LWR 
Advisory Committee Cardiovascular
Clinical TrialsNCT01368666
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a new Perceval device model, the Perceval PLUS Sutureless Heart Valve, including a modification to the bovine pericardial tissue chemical treatment process and a reduction of the inflow ring height for the size XL valve.
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