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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.
 
Trade NameANCURE ENDOGRAFT SYSTEM/ILIAC BALLOON CATHETER
Classification Namesystem, endovascular graft, aortic aneurysm treatment
ApplicantGUIDANT CARDIAC AND VASCULAR SURGERY
PMA NumberP990017
Supplement NumberS006
Date Received03/15/2000
Decision Date04/14/2000
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a hydrophilic coating with the trade name hydracoat to the outer surface of the ancure delivery catheter jacket.
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