FDA Approval of Cardiac Implantable Electronic Devices via Original and Supplement Premarket Approval Pathways, 1979-2012 - Rome, Benjamin N; Kramer, Daniel B; Kesselheim, Aaron S (JAMA : the journal of the American Medical Association, 2014)
Keywords: Biological and medical sciences; Changes; Defibrillators; Defibrillators, Implantable - adverse effects; Defibrillators, Implantable - standards; Device Approval - standards; Equipment Safety; FDA approval; General aspects; Medical sciences; Pacemaker, Artificial - adverse effects; Pacemaker, Artificial - standards; Product design; Product safety; Product Surveillance, Postmarketing; United States; United States Food and Drug Administration; United States; North America; America; Heart; Medicine; Electronics; Medical device; Circulatory system; Supplementation