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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceAutus Size-Adjustable Valve
Generic NameHeart-valve, polymeric
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP260007
Date Received02/09/2026
Decision Date10/01/2026
Product Code SJL 
Advisory Committee Cardiovascular
Clinical TrialsNCT05006404
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for AUTUS Size-Adjustable Valve: The AUTUS valve is indicated for the management of pediatric patients weighing greater than or equal to 10 kg who require surgical pulmonary valve replacement for dysfunctional native or surgically-repaired right ventricular outflow tract (RVOT), as determined by echocardiography to meet the following criteria: (1) severe pulmonary stenosis (i.e., right ventricle (RV) to pulmonary artery (PA) peak instantaneous gradient greater than or equal to 60 mmHg); (2) greater than or equal to moderate pulmonary regurgitation; or (3) greater than or equal to moderate pulmonary stenosis (i.e., RV to PA peak instantaneous gradient greater than or equal to 40 mmHg) and greater than or equal to moderate pulmonary regurgitation.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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