DevicePMAs@therightstef:P110023_S012 JSONTXT

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.