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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 TUBE AND BIFURCATED SYSTEMS & ILIAC BALLOON CATHETER
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendovascular tube & bifurcated graft systems
ApplicantGUIDANT CORP.
PMA NumberP990017
Supplement NumberS001
Date Received09/30/1999
Decision Date10/20/1999
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new manufacturing facility located at guidant corporation, 1525 o'brien drive, menlo park, ca.
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