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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.
 
DeviceANCURE/AORTOILIAC ENDOGRAFT SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantBoston Scientific Corp.
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP990017
Supplement NumberS030
Date Received12/19/2001
Decision Date04/24/2002
Withdrawal Date 09/19/2011
Product Code 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 ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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