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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.
 
DeviceGORE TAG Thoracic Branch Endoprosthesis (TBE Device)
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantW. L. Gore & Associates, Inc.
3450 West Kiltie Lane
Flagstaff, AZ 86005
PMA NumberP210032
Date Received08/24/2021
Decision Date05/13/2022
Product Code MIH 
Docket Number 22M-0813
Notice Date 05/17/2022
Advisory Committee Cardiovascular
Clinical TrialsNCT02777593
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for the GORE® TAG® Thoracic Branch Endoprosthesis. The device is intended for endovascular repair of lesions of the descending thoracic aorta, while maintaining flow into the left subclavian artery, in patients who are at high risk for debranching subclavian procedures.
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 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 
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