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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 NumberS031
Date Received09/24/2009
Decision Date03/23/2010
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding the 45mm tag thoracic endoprosthesis to the already existing tag thoracic endoprosthesis product family. The tag device is indicated for endovascular repair of aneurysms of the descending thoracic aorta in patients who have appropriate anatomy, including adequate iliac/ femoral access, aortic inner diameter in the range of 23-42mm, and >=2cm non-aneurysmal aorta proximal and distal to the aneurysm.
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