Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN110011 added)

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Presentations and Webcast Links added to Public Workshop

The Food and Drug Administration (FDA) announced the following “CDRH Veteran Amputee Device Workshop.” The purpose of this workshop was to engage all stakeholders involved in the research, development, and marketing of prosthetic limb medical devices used by veteran amputees. A specific goal was to engage veteran amputees who use prosthetic limb medical devices and…

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN160001 added)

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Consumer Information on: AMPLATZER PFO Occluder

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: AMPLATZER PFO OccluderPMA Applicant: St….

Class I Medical Device Recall: HeartWare Recalls Ventricular Assist Device Controllers Due to Loose Connectors which may Prevent Alarm from Sounding and Pump Stops

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UPDATE: SynCardia Systems – TAH-t Companion 2 Driver System (C2) and Freedom Driver System

Table 2. Patients Who Did NOT Receive Pre-Implant Circulatory Rescue Intervention (January 2016 report) Stroke and Other Neurological Adverse Events The most recent post-approval study results suggest that there is also a difference in clinical performance between the C2 Driver System and the CSS Console in terms of neurological adverse events.   The INTERMACS Neurological…

Waiver and Acknowledgment letters posted for November 9-10, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee

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