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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 SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System
Generic NamePulmonary valve prosthesis percutaneously delivered
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP200015
Date Received03/09/2020
Decision Date08/31/2020
Product Code NPV 
Docket Number 20M-1835
Notice Date 09/02/2020
Advisory Committee Cardiovascular
Clinical TrialsNCT02744677
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System with Commander Delivery System is indicated for use in the management of pediatric and adult patients who have a clinical indication for intervention on a dysfunctional right ventricular outflow tract (RVOT) conduit or surgical bioprosthetic valve in the pulmonic position with greater than or equal to moderate regurgitation and/or a mean RVOT gradient of greater than or equal to 35 mmHg.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S003 S004 S005 S006 S007 S021 S022 S023 S012 S013 S034 S035 
S036 S037 S017 S030 S031 S032 S042 S043 S047 S054 S061 S062 
S067 S057 S058 S052 S071 S053 S044 S045 S046 S072 S073 S074 
S075 S068 S069 S070 S066 S060 S076 S078 S079 S080 S081 S001 
S002  S009 S010 S011 S008 S014 S015 S016 S018 S019 S020 
S033 S024 S026 S027 S028 S029 S041 S038 S039 S040 S063 S064 
S065 S055 S056 S048 S049 S050 S051 S059 
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