DevicePMAs@therightstef:P050017_S006 JSONTXT 11 Projects

Approval for a product line extension that represents modifications to the 6fr version of the zilver vascular stent. in addition, approval of minor changes to the stent and delivery system and the addition of a 100 mm length stent. the device, as modified, will be marketed under the trade name zilver flex 35 vascular stent and is indicated for use as an adjunct to percutaneous transluminal angioplasty (pta) in the treatment of symptomatic vascular disease of the iliac arteries up to 100 mm in length, with a reference vessel diameter of 5 to 9 mm. Patients must be suitable for pta and stent treatment.