DevicePMAs@therightstef:P970020_S023 JSONTXT 11 Projects

Approval for the acs multi-link rx and otw tetra(tm) coronary stent systems. The devices are indicated for improving coronary lumen diameter in the following: 1) patients with symptomatic ischemic disease due to discrete de novo or restenotic native coronary artery lesions (length <= 25 mm) with a reference vessel diameter of 3.0 mm to 4.0 mm; and 2) treatment of abrupt or threatened abrupt closure in patients with failed interventional therapy in lesions (<= 35 mm in length) with reference diameters in the range of 2.5 mm to 4.0 mm. Long term outcome for this permanent implant is unknown at present. Note: the 2.5 mm and 2.75 mm diameter stents and the 33 mm and 38 mm length stents are solely indicated for use in patients with abrupt or threatened abrupt closure.