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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Namesystem, endovascular graft, aortic aneurysm treatment
15420 laguna canyon road
suite 260
irvine, CA 92618
PMA NumberP110032
Date Received08/15/2011
Decision Date02/14/2013
Product Code
MIH[ Registered Establishments with MIH ]
Docket Number 13M-0282
Notice Date 03/13/2013
Advisory Committee Cardiovascular
Clinical Trials NCT00522535
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the aorfix aaa flexible stent graft system. This device is indicated for the treatment of patients with abdominal aortic and aorto-iliac aneurysms having vascular morphology suitable for endovascularrepair, including:1) adequate iliac or femoral access that is compatible with vascular access techniques, implants, and accessories; 2) aortic neck landing zone diameters with a range of 19mm to 29mm; 3) non aneurysmal proximal neck center-line length of >= l5mm; 4) lnfrarenal aortic neck angulations including those up to and including 90°; 5) common iliac landing zone diameters with a range of 9mm to 19mm; and 6) distal fixation length of >= 15mm.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S002 S003 S005 S006 S009 S010 S011