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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
PMA NumberP110032
Supplement NumberS002
Date Received04/18/2013
Decision Date06/17/2013
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for several modifications to the outer sheath of the delivery system. The device, as modified, will be marketed under the trade name aorfix aaa flexible stent graft system with aorflex delivery system and is indicated for treatment of patients with abdominal aortic and aorto-iliac aneurysms having vascular morphology suitable for endovascular repair, 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 15mm; 4) infrarenal 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.