GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS

FDA premarket approval P020004/S123 · decided 2016-02-29

Approval details

PMA number

P020004

Supplement

S123

Supplement type

Panel Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS

Generic name

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant

W. L. Gore & Associates, Inc.

Date received

2015-09-02

Decision date

2016-02-29

Days to decision

180 days

Decision code

APPR

Product code

MIH

Advisory committee

Cardiovascular

Expedited review

No

Location

Phonix, AZ

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

510(k) clearances by this applicant