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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.
 
DeviceGORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Namesystem, endovascular graft, aortic aneurysm treatment
Applicant
W.L. GORE & ASSOCIATES,INC
3450 west kiltie lane
p.o. box 2400
flagstaff, AZ 86003-2400
PMA NumberP020004
Supplement NumberS123
Date Received09/02/2015
Decision Date02/29/2016
Product Code
MIH[ Registered Establishments with MIH ]
Docket Number 16M-0928
Notice Date 03/15/2016
Advisory Committee Cardiovascular
Clinical Trials NCT01883999
Supplement Typepanel track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the gore® excluder® iliac branch endoprosthesis (ibe device). This device is indicated for use with the gore® excluder® aaa endoprosthesis to isolate the common iliac artery from systemic blood flow and preserve blood flow in the external iliac and internal iliac arteries in patients with a common iliac or aortoiliac aneurysm, who have appropriate anatomy, including: 1) adequate iliac/ femoral access; 2) minimum common iliac diameter of 17 mm at the proximal implantation zone of the ibe; 3) external iliac artery treatment diameter range of 6. 5 – 25 mm and seal zone length of at least 10 mm; 4) internal iliac artery treatment diameter range of 6. 5 – 13. 5 mm and seal zone length of at least 10 mm; and 5) adequate length from the lowest major renal artery to the internal iliac artery to accommodate the total endoprosthesis length, calculated by adding the minimum lengths of required components, taking into account appropriate overlaps between components.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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