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Consumer Information on: Edwards SAPIEN XT Transcatheter Heart Valve
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: Edwards SAPIEN XT Transcatheter Heart…
Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization
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February 18, 2016 MDUFA III Performance Report
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Hydrogen Peroxide Contact Lens Solution
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Zika Virus Emergency Use Authorization – Zika MAC
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: Cook Medical Expands Recall for Beacon Tip Angiographic Catheters to Include Additional Product Lots
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FDA-Industry MDUFA IV Reauthorization Meeting, January 20, 2016
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FDA-Industry MDUFA IV Reauthorization Meeting, January 27, 2016
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Neurosurgical Head Holders (Skull Clamps) and Device Slippage: FDA Safety Communication
Date Issued: February 25, 2016 Audiences: Health care providers who use neurosurgical head holders, including: Ear, Nose and Throat Specialists, Neurological Surgeons, Orthopaedic Surgeons and Operating Room Staff Hospital staff responsible for maintenance of medical devices Medical Specialties: Neurosurgery, Otolaryngology, Orthopaedics Device: A neurosurgical head holder (skull clamp) system is a device used to secure…