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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
799 international parkway
sunrise, FL 33325
PMA NumberP110038
Date Received11/04/2011
Decision Date09/21/2012
Product Code
MIH[ Registered Establishments with MIH ]
Docket Number 12M-1012
Notice Date 10/02/2012
Advisory Committee Cardiovascular
Clinical Trials NCT00435942
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the relay thoracic stent-graft with plus delivery system. This device is indicated for the endovascular repair of fusiform aneurysms and saccular aneurysms/ penetrating atherosclerotic ulcers in the descending thoracic aorta in patients having appropriate anatomy, including: 1) iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices and/or accessories; 2) non-aneurysmal aortic neck diameter in the range of 19 - 42 mm; and 3) non-aneurysmal proximal aortic neck lengths between 15 and 25 nun and distal aortic neck lengths between 25 and 30 mm depending on the diameter stent-graft required.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S004 S005 S006 S008 S009 S010 S011 
S012 S014