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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceGore Excluder Conformable AAA Endoprosthesis (CEXC)
Generic Namesystem, endovascular graft, aortic aneurysm treatment
Applicant
W. L. Gore and Associates, Inc.
32360 n. north valley parkway
phoenix, AZ 85085
PMA NumberP200030
Date Received06/29/2020
Decision Date12/22/2020
Product Code MIH 
Docket Number 20M-2339
Notice Date 12/23/2020
Advisory Committee Cardiovascular
Clinical Trials NCT02489539
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for Gore Excluder Conformable AAA Endoprosthesis (EXCC)This device is indicated to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (AAA) disease and who have appropriate anatomy as described below:1) Adequate iliac / femoral access;2) Infrarenal aortic neck treatment diameter range of 16–32 mm;3) A minimum aortic neck length of 15 mm when proximal aortic neck angulation is =<60 degrees; and4) Iliac artery treatment diameter range of 8–25 mm and iliac distal vessel seal zone length of at least 10 mm.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 
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