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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.
 
DeviceTriClip G4 System
Generic NameTricuspid valve repair device, percutaneously delivered
ApplicantAbbott Medical
177 Country Road B East
St.Paul, MN 55117
PMA NumberP230007
Date Received03/02/2023
Decision Date04/01/2024
Product Code NPS 
Advisory Committee Cardiovascular
Clinical TrialsNCT03904147
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the TriClip G4 System. This device is indicated for improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, who are at intermediate or greater risk for surgery and in whom transcatheter edge-to-edge valve repair is clinically appropriate and is expected to reduce tricuspid regurgitation severity to moderate or less, as determined 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 S003 S004 
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