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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 EXCLUDER Thoracoabdominal Branch Endoprosthesis
Generic NameEndovascular system for treatment of thoracoabdominal and pararenal aortic lesions
ApplicantW.L. Gore & Associates, Inc.
3450 W. Kiltie Lane
Flagstaff, AZ 86005
PMA NumberP230023
Date Received07/19/2023
Decision Date01/12/2024
Product Code QZK 
Docket Number 24M-0525
Notice Date 02/21/2024
Advisory Committee Cardiovascular
Clinical TrialsNCT05442489
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis. This device is indicated for endovascular repair in patients with thoracoabdominal aortic aneurysms and high-surgical risk patients with pararenal aortic aneurysms who have appropriate anatomy.
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 
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