1. Metal expandable biliary stents: premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration Staff Publication: Silver Spring, MD : Center for Drug Evaluation and Research, July 27, 2019 Subject(s): Bile DuctsDevice Approval -- standardsSelf Expandable Metallic Stents -- standardsBiocompatible Materials -- standardsMaterials Testing -- standardsProduct Labeling -- standardsProduct Packaging -- standardsSterilization -- standardsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
