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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
Generic Namesystem, endovascular graft, aortic aneurysm treatment
32360 n. north valley parkway
phoenix, AZ 85085
PMA NumberP020004
Supplement NumberS123
Date Received09/02/2015
Decision Date02/29/2016
Product Code MIH 
Docket Number 16M-0928
Notice Date 03/15/2016
Advisory Committee Cardiovascular
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling Part 2