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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 NameTHE ANEURX STENT GRAFT WITH XPEDIENT DELIVERY SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nametransluminal graft prosthesis for the treatment of abdominal aortic aneurysms
ApplicantMEDTRONIC AVE, INC.
PMA NumberP990020
Supplement NumberS009
Date Received06/03/2002
Decision Date11/21/2002
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the xpedient delivery system. The device, as modified, will be marketed under the trade name aneurx stent graft with expedient delivery system and is indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms having: 1) infrarenal, non-aneurysmal, neck length of greater than 1 cm at the proximal and distal ends of the aneurysm and an inner vessel diameter approximately 10-20% smaller than the labeled device diameter: 2) morphology suitable for endovascular repair; 3) one of the following: a) aneurysm diameter > 5 cm; b) aneurysm diameter of 4-5 cm which has also increased in size by 0. 5 cm in the last 6 months; or c) aneurysm which is twice the diameter of the normal infrarenal aorta.
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