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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.
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendovascular graft
PMA NumberP040043
Supplement NumberS051
Date Received03/14/2013
Decision Date09/10/2013
Product Code
MIH[ Registered Establishments with MIH ]
Docket Number 13M-1323
Notice Date 10/24/2013
Advisory Committee Cardiovascular
Clinical Trials NCT00908388
Supplement Typepanel track
Supplement Reason change design/components/specifications - component
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. This device is intended for endovascular repair of all lesions of the descending thoracic aorta, including: 1) isolated lesions in patients who have appropriate anatomy, including: a) adequate iliac i femoral access; b) aortic inner diameter in the range of 16-42 mm; and c) > 20 mm non-aneurysmal aorta proximal and distal to the lesion. 2) type b dissections in patients who have appropriate anatomy, including: a) adequate iliac i femoral access; b) > 20 mm landing zone proximal to the primary entry tear; proximal extent of the landing zone must not be dissected; and c) diameter at proximal extent of proximal landing zone in the range of 16-42 mm.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress