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Device | ASTRON PERIPHERAL SELF-EXPANDING NITINOL STENT SYSTEM |
Generic Name | STENT, ILIAC |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P140030 |
Date Received | 12/18/2014 |
Decision Date | 12/17/2015 |
Product Code |
NIO |
Docket Number | 15M-4947 |
Notice Date | 12/22/2015 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01319812
|
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
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Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 |