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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceOMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEM
Generic NameSTENT, ILIAC
ApplicantABBOTT VASCULAR-CARDIAC THERAPIES
3200 LAKESIDE DR.
SANTA CLARA, CA 95054-2807
PMA NumberP110043
Date Received12/30/2011
Decision Date07/31/2012
Product Code NIO 
Docket Number 12M-0833
Notice Date 08/03/2012
Advisory Committee Cardiovascular
Clinical TrialsNCT00844532
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM. THIS DEVICE IS INDICATED FOR THE TREATMENT OF ATHEROSCLEROTIC ILIAC ARTERY LESIONS WITH REFERENCE VESSEL DIAMETERS OF >= 5.0 MM AND <= 11.0 MM AND LESION LENGTHS UP TO 50 MM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S006 S007 S008 S009 S010 S011 S012 
S013 
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