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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 ENDOCRAFT SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendovascular grafting system
ApplicantGUIDANT CARDIAC AND VASCULAR SURGERY
PMA NumberP990017
Supplement NumberS034
Date Received06/26/2002
Decision Date07/24/2002
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the manufacturing process for the ancure endograft system to add an inspection step in one manufacturing procedure for the contralateral pullwire.
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