title: Publication of Clinical Studies Supporting FDA Premarket Approval for High-Risk Cardiovascular Devices Between 2011 and 2013: A Cross-sectional Study.
authors.affiliation: Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.
authors.forename: Adam T
authors.initials: AT
authors.lastname: Phillips
authors.affiliation: medical student, Yale University School of Medicine, New Haven, Connecticut.
authors.forename: Vinay K
authors.initials: VK
authors.lastname: Rathi
authors.affiliation: Robert Wood Johnson Foundation Clinical Scholars Program, Section of General Internal Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut4Department of Health Policy and Management, Yale University School.
authors.forename: Joseph S
authors.initials: JS
authors.lastname: Ross
mesh_terms: D002318:Cardiovascular Diseases / Q000628:therapy*; D000068456:Clinical Studies as Topic / Q000706:statistics & numerical data*; D003430:Cross-Sectional Studies; D018795:Device Approval; D006350:Heart Valve Prosthesis; D006801:Humans; D019736:Prostheses and Implants; D011643:Publishing / Q000706:statistics & numerical data*; D015607:Stents; D014481:United States; D014486:United States Food and Drug Administration