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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
Generic Nameheart-valve, non-allograft tissue
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP150048
Supplement NumberS012
Date Received12/01/2017
Decision Date08/09/2018
Product Code LWR 
Advisory Committee Cardiovascular
Clinical TrialsNCT01757665
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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