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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameGORE TAG THORACIC ENDOPROSTHESIS
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendovascular graft
ApplicantW.L. GORE & ASSOCIATES,INC
PMA NumberP040043
Supplement NumberS040
Date Received07/19/2011
Decision Date01/13/2012
Product Code
MIH[ Registered Establishments with MIH ]
Docket Number 12M-0056
Notice Date 01/19/2012
Advisory Committee Cardiovascular
Clinical Trials NCT00917852
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the gore tag thoracic endoprosthesis. The device is intended for endovascular repair of isolated lesions (not including dissections) of the descending thoracic aorta, in patients who have appropriate anatomy including adequate iliac/femoral access, aortic inner diameter in the range of 16-42 mm, and >= 20 mm non-aneurysmal aorta proximal and distal to the lesion.
Approval Order Approval Order
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