|Trade Name||EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM|
|Classification Name||stent, superficial femoral artery|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to add the 5f entrust otw delivery system. The device, as modified, will be marketed under the trade name everflex self-expanding peripheral stent with entrust delivery system and is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140mm in length in the native superficial femoral artery (sfa) and/or proximal popliteal arteries with reference vessel diameters ranging from 4. 5-7. 5mm.