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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
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: S009 S020 S021 S032 S012 S013 S014 S015 S016 S005 S006 S007 
S035 S036 S037 S038 S039 S040 S041 S046  S024 S026 S027 
S028 S029 S030 S017 S010 S042 S033 S034 S008 S031 S022 S023 
S001 S002 S003 S004 S018 S019 S011 S049 S050 S051 S052 S053 
S047 S048 S043 S044 S045 
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