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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
Classification Nameaortic valve, prosthesis, percutaneously delivered
Generic Nameaortic valve, prosthesis, percutaneously delivered
one edwards way
irvine, CA 92614
PMA NumberP130009
Supplement NumberS037
Date Received07/01/2015
Decision Date02/29/2016
Product Code
NPT[ Registered Establishments with NPT ]
Docket Number 16M-0926
Notice Date 03/15/2016
Advisory Committee Cardiovascular
Clinical Trials NCT00676689
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use in pediatric and adult patients with a dysfunctional, non-compliant Right Ventricular Outflow Tract (RVOT) conduit with a clinical indication for intervention and: 1) pulmonary regurgitation >= moderate and/or; and 2) mean RVOT gradient >= 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