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

FDA premarket approval P200015 · decided 2020-08-31

Approval details

PMA number
P200015
Trade name
Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System
Generic name
Pulmonary valve prosthesis percutaneously delivered
Applicant
Edwards Lifesciences, LLC
Date received
2020-03-09
Decision date
2020-08-31
Days to decision
175 days
Decision code
APPR
Product code
NPV
Advisory committee
Cardiovascular
Expedited review
No
Location
Irvine, CA
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.

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