Federal Register Notice: FDA has determined the regulatory review period for Medtronic Vascular’s S8 Over-the-Wire System is 652 days for extending a patent which claims that medical device. The S8 System is 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 predilatation. To view this notice, click here.