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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 Heart Valve
Generic Nameheart-valve, non-allograft tissue
ApplicantCorcym S.r.l.
Via Crescentino Sn
Saluggia 13040
PMA NumberP150011
Supplement NumberS015
Date Received01/22/2019
Decision Date02/08/2019
Product Code LWR 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
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 labeling changes to instruct users on safe, future valve-in-valve implantations.
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