|Trade Name||MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM|
|Classification Name||stent, superficial femoral artery|
|Applicant||TERUMO MEDICAL CORPORATION|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the misago peripheral self-expanding stent system. This device is indicated to improve luminal diameter in symptomatic patients with de novo or restenotic native lesions or occlusions of the superficial femoral artery (sfa) and/or proximal popliteal artery with reference vessel diameters ranging from 4mm to 7mm and lesion length up to 150mm.