Approval Order Statement Approval for the driver over-the-wire, rapid exchange, and multi-exchange coronary stent systems. These devices are indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions with reference vessel diameters of 3. 0 - 4. 0 mm and <= 30 mm in length using direct stenting or pre-dilatation. Outcome beyond 270 days for this permanent implant is unknown at present.