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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.
 
DeviceASTRON PERIPHERAL SELF-EXPANDING NITINOL STENT SYSTEM
Generic NameSTENT, ILIAC
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP140030
Date Received12/18/2014
Decision Date12/17/2015
Product Code NIO 
Docket Number 15M-4947
Notice Date 12/22/2015
Advisory Committee Cardiovascular
Clinical TrialsNCT01319812
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ASTRON PERIPHERAL SELF-EXPANDING STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETERIN PATIENTS WITH ILIAC ATHEROSCLEROTIC LESIONS IN VESSEL REFERENCE DIAMETERS BETWEEN 4.3MM AND9.5MM AND LESION LENGTHS UP TO 105MM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 
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