DevicePMAs@therightstef:P110019_S075 JSONTXT 11 Projects

Approval for the xience v and xience nano everolimus eluting coronary stent system, xience prime and xience prime ll everolimus eluting coronary stent system, xience xpedition, xience xpedition sv and xience xpedition ll everolimus eluting coronary stent system and xience alpine everolimus eluting coronary stent system. these devices are indicated for the following: xience v and xience nano everolimus eluting coronary stent system. The xience v everolimus eluting coronary stent system (xience v stent) is indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions (length <= 28 mm) with reference vessel diameters of 2.25 mm to 4.25 mm. additionally, the xience v stent is indicated for treating de novo chronic total coronary occlusions. xience prime and xience prime ll everolimus eluting coronary stent system. The xience prime stent system is indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions (length <= 32 mm) with reference vessel diameters of >=2.25 mm to <= 4.25 mm. additionally, the xience prime stent system is indicated for treating de novo chronic total coronary occlusions. Xience xpedition, xience xpedition sv and xience xpedition ll everolimus eluting coronary stent system. the xience xpedition stent system is indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions (length <= 32mm) with reference vessel diameters of >= 2.25 mm to <= 4.25 mm. in addition, the xience xpedition stent system is indicated for treating de novo chronic total coronary occlusions. For additional information please refer to the approval order.