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Device | GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | W.L. GORE & ASSOCIATES,INC 32360 N. North Valley Parkway Phoenix, AZ 85085 |
PMA Number | P020004 |
Supplement Number | S123 |
Date Received | 09/02/2015 |
Decision Date | 02/29/2016 |
Product Code |
MIH |
Docket Number | 16M-0928 |
Notice Date | 03/15/2016 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01883999
|
Supplement Type | Panel 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 Study | Show Report Schedule and Study Progress |