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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.
 
DeviceASTRON PERIPHERAL SELF-EXPANDING NITINOL STENT SYSTEM
Classification Namestent, iliac
Generic Namestent, iliac
Applicant
BIOTRONIK, INC.
6024 jean road
lake oswego, OR 97035
PMA NumberP140030
Date Received12/18/2014
Decision Date12/17/2015
Product Code
NIO[ Registered Establishments with NIO ]
Docket Number 15M-4947
Notice Date 12/22/2015
Advisory Committee Cardiovascular
Clinical Trials NCT01319812
NCT01661231
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 
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