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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 Ave. N
St Paul, MN 55112
PMA NumberP990017
Supplement NumberS030
Date Received12/19/2001
Decision Date04/24/2002
Withdrawal Date09/19/2011
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
Predetermined Change Control Plan AuthorizedNo
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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