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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 ENDOVASCULAR GRAFT TUBE AND BIFURCATED SYSTEMS
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendovascular grafting system
ApplicantGUIDANT CORP.
PMA NumberP990017
Supplement NumberS011
Date Received09/25/2000
Decision Date09/20/2001
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the five year follow-up protocol: a) changing the follow-up schedule; b) removing the ultrasound and ankle brachial indices (abi) assessments; c) replacing the annual physical exam for control patients with an annual telephone survey and computed tomography (ct) and physical exam at the five year mark; d) allowing an optional telephone survey for patients unable or unwilling to come to the investigational site; and e) excluding patients who have been converted from further study follow-up.
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