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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
PMA NumberP120006
Date Received04/11/2012
Decision Date10/05/2012
Product Code
MIH[ Registered Establishments with MIH ]
Docket Number 12M-1110
Notice Date 11/08/2012
Advisory Committee Cardiovascular
Clinical Trials NCT01092117
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the ovation abdominal stent graft system. This device is indicated for treatment of patients with abdominal aortic aneurysms having vascular morphology suitable for endovascular repair, including: 1) adequate iliac/femoral access compatible with vascular access techniques, devices, and/or accessories; 2) non-aneurysmal proximal aortic neck: a) with a length of at least 7 mm proximal to the aneurysm; b) with an inner wall diameter of no less than 16 mm and no greater than 30 mm; and c) with an aortic angle of <= 60 degrees if proximal neck is >= 10 mm and <=45 degrees if proximal neck is <10 mm. 3) adequate distal iliac landing zone: a) with a length of at least 10 mm; and with an inner wall diameter of no less than 8 mm and no greater than 20 mm.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S003 S004 S005 S006 S007 S008 S009 S010 
S011 S013 S014 S015 S016 S017 S018 S019 S020