Department of Health and Human ServicesĬenter for Devices and Radiological HealthĬontains Nonbinding Recommendations Preface Public CommentĬomments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. This document supersedes the guidance “Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems” dated January 13, 2005.įor questions regarding this document, contact the Interventional Cardiology Devices Branch at or the Peripheral Interventional Devices Branch at (301) 796-7000. George’sVascular Institute, St George’s Hospital, London, United Kingdom (K.I.P.) Department of Vascular Surgery, University of Patras, Patras, Greece (S.K.K.) Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia (J.G.On August 18, 2015, FDA issued the final guidance Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems which updates and augments (but not replaces) this guidance. George’sVascular Institute, St George’s Hospital, London, United Kingdom (K.I.P.) Department of Vascular Surgery, University of Patras, Patras, Greece (S.K.K.) Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia (J.G.) Department of Vascular and Endovascular Surgery, The Townsville Hospital, Townsville, Queensland, Australia (J.G.) Department for Vascular and Endovascular Surgery, Klinikum Rechts der Isar, Technical University Munich, Munich, Germany (H.-H.E.) Department of Medicine, Michigan State University, Metro Health Hospital, Grand Rapids, MI (L.J.D.-S.) Cardiology Department, Xiamen Cardiovascular Hospital, Xiamen, Fujian, China (L.C.) Center for Cardiology Intervention Treatment, Department of Cardiology, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China (Q.F.) Stroke Unit, Department of Neurology, Western Hospital, University of Melbourne, Footscray, Melbourne, Victoria, Australia (T.W.) Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China (T.W.L.) Department of Vascular Surgery, University of Arizona and Pima Vascular Group, Tucson (M.M.-B.) Department of Neurology, Hallym Neurological Institute, Hallym University, Sacred Heart Hospital, Seoul, South Korea (B.-C.L.) Centre for Health and Social Research, Faculty of Health Sciences, Australian Catholic University, Melbourne, Victoria, Australia (S.P.) and Department of Neurology, University Hospital Heidelberg, Heidelberg, Germany (P.R.).įrom the Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine (A.L.A, M.D.), Department of Surgery, Central Clinical School (M.B.), Monash University, Melbourne, Victoria, Australia Neurology Department, The Alfred Hospital, Prahran, Victoria, Australia (A.L.A.) Department of Cardiovascular Sciences, St. Customer Service and Ordering Informationįrom the Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine (A.L.A, M.D.), Department of Surgery, Central Clinical School (M.B.), Monash University, Melbourne, Victoria, Australia Neurology Department, The Alfred Hospital, Prahran, Victoria, Australia (A.L.A.) Department of Cardiovascular Sciences, St.Stroke: Vascular and Interventional Neurology.

Journal of the American Heart Association (JAHA).Circ: Cardiovascular Quality & Outcomes.Arteriosclerosis, Thrombosis, and Vascular Biology (ATVB).

Guideliner for stenting