DevicePMAs@therightstef:P110004_S001 JSONTXT

Approval for modifications to the stent delivery system. the device, as modified, will be marketed under the trade name nirxcell cocr coronary stent on rx system and is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease associated with stenotic lesions in de novo native coronary arteries (length 30mm) with a reference vessel diameter of 2.50mm to 4.00mm.