|Trade Name||NIROYAL(TM) ELITE OVER-THE-WIRE(OTW) STENT SYSTEM|
|Applicant||BOSTON SCIENTIFIC SCIMED, INC.|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the niroyal(tm) elite otw stent system. The device is indicated for improving coronary luminal diameter in the following: 1) patients with symptomatic ischemic disease due to discrete de novo lesions in native coronary arteries (lenth <=25 mm) in reference vessel diameter 3. 0 to 4. 0 mm; 2) treatment of abrupt or threatened closure in patients with failed interventional therapy in lesions with reference diameters in the range of 2. 5 to 4. 0 mm; and 3) patients with symptomatic heart disease due to lesions in saphenous vein bypass grafts with lesion length <=30 mm and reference diameter in the range of 3. 0 to 4. 0 mm.