FDAnews has teamed Chris Sloan, Quintiles Consulting, and Michael Morton, Medtronic, in a 90-minute presentation on the FDA advisory panel process. You’ll discover tips and guidance that are the fruit of a combined five decades of device regulatory experience.
Cordis stent defect leads to a field safety notice for its S.M.A.R.T. Control Nitinol stent system due to a potential sterility breach in the pouches of all unexpired lots. The Chinese Department of Health said the potential defect was detected during in-house testing on non-production product as part of a development project.