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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.
DeviceEdwards Pericardial Mitral Bioprosthesis, Model 11000M
Classification Nameheart-valve, non-allograft tissue
Generic Nameheart-valve, non-allograft tissue
one edwards way
irvine, CA 92614-5688
PMA NumberP150048
Supplement NumberS012
Date Received12/01/2017
Decision Date08/09/2018
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Clinical Trials NCT01757665
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Edwards Pericardial Mitral Bioprosthesis, Model 11000M. This device is indicated for the replacement of native or prosthetic mitral 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