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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 NumberS008
Date Received01/27/2017
Decision Date02/23/2017
Product Code LWR 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Implement a reprocessing step in the stent manufacturing process.
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