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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 NumberP020004
Supplement NumberS039
Date Received11/17/2008
Decision Date03/05/2009
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the 31 mm gore excluder endoprosthesis. The 31 mm gore excluders endoprosthesis includes two components that were not included in prior submissions: the 31 mm trunk-ipsilateral leg and the 32 mm aortic extender. The device, as modified, will be marketed under the trade name gore excluders aaa endoprosthesis and is intended to exclude the aneurysm from blood circulation in patients who have appropriate anatomy as follows: 1) adequate iliac/femoral access; 2) infrarenal aortic neck treatment diameter range of 19-29 mm and a minimum aortic neck length of 15 mm; 3) proximal aortic neck angulation less than or equal to 60 degrees; and 4) iliac artery treatment diameter range of 8-18. 5 mm and iliac distal vessel seal zone length of at least 10 mm.