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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.
 
DeviceEDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500)
Generic Nameheart-valve, non-allograft tissue
ApplicantEDWARDS LIFESCIENCES, LLC.
ONE EDWARDS WAY
IRVINE, CA 92614-5688
PMA NumberP150048
Date Received12/28/2015
Decision Date06/29/2017
Product Code LWR 
Docket Number 17M-3990
Notice Date 07/06/2017
Advisory Committee Cardiovascular
Clinical TrialsNCT01757665
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of the Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve. The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for the replacement of native or prosthetic aortic heart valves. The Edwards INSPIRIS RESILIA Aortic Valve, Model 11500A, is indicated for the replacement of native or prosthetic aortic heart valves.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S014 S015 S016 S017 S018 S024 S006 S034 S035 S036 S044 
S032 S047 S048 S037 S038 S029 S030 S060 S069 S055 S065 S071 
S053 S058 S059 S072 S073 S074 S007 S008 S009 S010 S011 S023 
S020 S001 S002 S003 S004 S005 S012 S025 S021 S022 S019 S013 
S027 S028 S031 S039 S040 S041 S042 S043 S049 S046 S026 S066 
S067 S068 S061 S062 S063 S064 S075 S052 S054 S056 S057 S050 
S051 S078 S079 S076 S077 
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