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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 NameANEURX AAADVANTAGE STENT GRAFT WITH XCELERANT DELIVERY SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nametransluminal graft prosthesis for the treatment of abdominal aortic aneurysms
ApplicantMEDTRONIC VASCULAR
PMA NumberP990020
Supplement NumberS020
Date Received06/24/2005
Decision Date03/17/2006
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 additional iliac sizes (including 18mm and 20mm diameters; flared iliac and iliac cuffs in 16 mm x 20mm, 18mm x 22mm, and 18mm x 24mm); a longer aortic body of the bifurcated component by 1 cm; pre-shaped (contoured) stent rings; and platinum-iridium radiopaque markets. The device, as modified, will be marketed under the trade name aneurx aaadvantage stent graft with xcelerant delivery system and is indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms having: 1) adequate iliac/femoral access; 2) 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; 3) morphology suitable for endovascular repair; 4) one of the following: aneurysm diameter > 5 cm; aneurysm diameter of 4-5 cm which has also increased in size by 0. 5 cm in the last 6 months; or aneurysm which is twice the diameter of the normal infrarenal aorta.
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