Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System

FDA Premarket Approval P200015

Pre-market Approval Supplement Details

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.

DeviceEdwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System
Generic NamePulmonary Valve Prosthesis Percutaneously Delivered
ApplicantEdwards Lifesciences, LLC
Date Received2020-03-09
Decision Date2020-08-31
Notice Date2020-09-02
Product CodeNPV 
Docket Number20M-1835
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address Edwards Lifesciences, LLC one Edwards Way irvine, CA 92614
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P200015Original Filing
S032 2022-11-14 30-day Notice
S031 2022-10-25 30-day Notice
S030 2022-10-04 30-day Notice
S027 2022-08-25 30-day Notice
S023 2022-06-30 30-day Notice
S022 2022-06-06 30-day Notice
S021 2022-05-25 Normal 180 Day Track No User Fee
S019 2022-04-04 30-day Notice
S017 2022-01-14 30-day Notice
S016 2021-11-03 Normal 180 Day Track No User Fee
S015 2021-10-19 30-day Notice
S014 2021-09-30 30-day Notice
S013 2021-08-30 30-day Notice
S012 2021-08-25 30-day Notice
S010 2021-06-07 Normal 180 Day Track No User Fee
S009 2021-03-19 Normal 180 Day Track No User Fee
S008 2021-02-22 30-day Notice
S007 2020-12-17 30-day Notice
S006 2020-12-03 30-day Notice
S004 2020-09-08 30-day Notice
S003 2020-11-17 30-day Notice
S002 2020-11-02 30-day Notice


Device IDPMASupp
00690103210866 P200015 011
00690103210873 P200015 011

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