|Trade Name||EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM|
|Classification Name||stent, superficial femoral artery|
|Supplement Type||panel track|
|Supplement Reason|| labeling change - indications|
|Expedited Review Granted?|| No|
||Labeling, Approval Order, Summary of Safety and Effectiveness|
|Approval Order Statement |
Approval for the everflex self-expanding peripheral stent system. This device is indicated for improving luminal diameter in patients with atherosclerotic disease in the common and/or external iliac arteries up to and including 100 mm in length, with a reference vessel diameter of 4. 5 ¿ 7. 5 mm.