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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.
 
DeviceANCURE ENDOGRAFT SYSTEM/ANCURE ILIAC BALLOON CATHETER
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Namesystem, endovascular graft, aortic aneurysm treatment
Applicant
Boston Scientific Corp.
4100 hamline avenue north
st. paul, MN 55112
PMA NumberP990017
Supplement NumberS005
Date Received02/08/2000
Decision Date03/24/2000
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add the ancure bifurcated endograft with differential limb lengths to the product line.
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