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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.
 
DeviceTendyne Transcatheter Mitral Valve System
Generic NameProsthesis, mitral valve, percutaneously delivered
ApplicantAbbott Medical
177 County Road B East
St. Paul, MN 55117
PMA NumberP240042
Date Received11/27/2024
Decision Date05/23/2025
Product Code NPU 
Docket Number 25M-1506
Notice Date 06/02/2025
Advisory Committee Cardiovascular
Clinical TrialsNCT03433274
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Tendyne Transcatheter Mitral Valve System. This device is indicated for the treatment of symptomatic severe mitral valve dysfunction (moderate-to-severe or severe mitral regurgitation [MR], severe mitral stenosis [MS], or moderate MR with moderate or greater MS) associated with severe mitral annular calcification (MAC) in patients who are deemed unsuitable for mitral valve surgery or transcatheter edge-to-edge repair by a multidisciplinary heart team.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 
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