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Consumer Information on: Absorb GT1™ Bioresorbable Vascular Scaffold (BVS) System
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name: Absorb GT1™ Bioresorbable Vascular Scaffold…
Transcripts posted for June 2-3, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee
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Webinar – An Update on the FDA’s Medical Device Clinical Trials Program
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Emergency Use Authorizations: Zika MAC-ELISA (CDC) Updated June 29, 2016
On February 26, 2016, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Centers for Disease Control and Prevention’s (CDC) Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) for the presumptive detection of Zika virus-specific IgM in human sera or cerebrospinal fluid (CSF) that is submitted alongside…
Class I Medical Device Recall: HeartWare Inc. Extends Recall to Include Batteries Used in the Ventricular Assist Device Due to Premature Power Depletion
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Meeting Notice: August 16, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-1660] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; establishment of a public docket; request for comments. SUMMARY: The Food and Drug Administration…
Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN 130051 and DEN150007 added)
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Patient and Consumer Stakeholder Meeting Minutes, May 27, 2016
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Webinar for FDA Final Guidance: Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices
On Monday, August 8, 2016, the FDA will host a webinar to share information and answer questions about its final guidance: Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices. This final guidance, issued on June 21, provides a framework to consider extrapolating existing data to evaluate a device’s performance in pediatric…