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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namestent, iliac
Generic Namestent, iliac
parkmore business park west
PMA NumberP110011
Date Received04/01/2011
Decision Date10/26/2011
Product Code
NIO[ Registered Establishments with NIO ]
Docket Number 11M-0791
Notice Date 11/04/2011
Advisory Committee Cardiovascular
Clinical Trials NCT00753337
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the assurant cobalt iliac balloon-expandable stent system. This device is indicated for improving iliac luminal diameter in patients with de novo and restenotic lesions in the common and external iliac arteries, with reference vessel diameters between 6 mm and 10 mm and lesion lengths up to 61 mm. The stent is intended as a permanent implant.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S012