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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.
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Namesystem, endovascular graft, aortic aneurysm treatment
Boston Scientific Corp.
4100 hamline avenue north
st. paul, MN 55112
PMA NumberP990017
Supplement NumberS030
Date Received12/19/2001
Decision Date04/24/2002
Product Code
MIH[ Registered Establishments with MIH ]
Docket Number 02M-0298
Notice Date 07/02/2002
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 ancure aortoiliac system. This device is indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms in patients whose anatomy does not allow the use of a tube or bifurcated device.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling