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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DevicePERCEVAL SUTURELESS HEART VALVE
Generic Nameheart-valve, non-allograft tissue
ApplicantCorcym S.r.l.
Via Crescentino sn
Saluggia 13040
PMA NumberP150011
Date Received03/02/2015
Decision Date01/08/2016
Product Code LWR 
Docket Number 16M-0123
Notice Date 01/11/2016
Advisory Committee Cardiovascular
Clinical TrialsNCT01368666
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the Perceval Sutureless Heart Valve. This device is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S022 S023 S024 
S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 
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