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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
Classification Nameheart-valve, non-allograft tissue
Generic Nameheart-valve, non-allograft tissue
one edwards way
irvine, CA 92614-5688
PMA NumberP150048
Date Received12/28/2015
Decision Date06/29/2017
Product Code
LWR[ Registered Establishments with LWR ]
Docket Number 17M-3990
Notice Date 07/06/2017
Advisory Committee Cardiovascular
Clinical Trials NCT01757665
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve. The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for the replacement of native or prosthetic aortic heart valves. The Edwards INSPIRIS RESILIA Aortic Valve, Model 11500A, is indicated for the replacement of native or prosthetic aortic heart valves.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S006 S007 S008 S009 S010 
S013 S014 S015 S016 S017 S018 S019 S020