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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
Applicant
Edwards 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 Trials NCT02744677
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 
S009 S010 S012 S013 
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