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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
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendovascular grafting system
ApplicantGUIDANT CARDIAC AND VASCULAR SURGERY
PMA NumberP990017
Supplement NumberS029
Date Received11/29/2001
Decision Date12/11/2001
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for temporary addition of a label to inspect the contralateral cutter packaged with the ancure device. The change would apply to 436 devices manufactured between october 12, 2001 and november 12, 2001.
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