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
PMAP200015
SupplementS
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

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Supplement NumberDateSupplement Type
P200015Original Filing

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