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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.
 
DeviceRELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Namesystem, endovascular graft, aortic aneurysm treatment
Applicant
BOLTON MEDICAL, INC.
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 
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