Recall Class: Class I Date Recall Initiated: July 2, 2015 Device: Beacon Tip Torcon NB Advantage Catheters, Beacon Tip Royal Flush Plus High-Flow Catheters, Slip-Cath Beacon Tip Catheters Lot numbers: Complete list of lot numbers Manufactured from: May 9, 2013 to September 1, 2014 Distributed from: June 6, 2013 to June 25, 2015 Devices Recalled…
Summary Information for: ORBERA™ Intragastric Balloon System
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PMA Final Decisions for May 2015
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FDA Voice blog: Advancing precision medicine by enabling a collaborative informatics community
By: Taha A. Kass-Hout, M.D., M.S., and David Litwack, Ph.D. FDA plays an integral role in President Obama’s Precision Medicine Initiative, which foresees the day when an individual’s medical care will be tailored in part based on their unique characteristics and genetic make-up. Yet while more than 80 million genetic variants have been found in…
Mammography Facility Adverse Event and Action Report
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Consumer Information on: ORBERA™ Intragastric Balloon System
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Serious Adverse Events with Implantable Left Ventricular Assist Devices (LVADs): FDA Safety Communication
Date Issued: August 5, 2015 Audiences: Health care providers treating heart failure patients Patients with a LVAD Caregivers of patients with a LVAD Specialties: Cardiology, Cardiac Surgery, Heart Failure, Heart Transplantation Product: Implantable LVADs help the left ventricle (the main pumping chamber of the heart) circulate blood throughout the body in patients with advanced heart…
Updated FDA Approved Obesity Treatment Devices
Currently, there are three types of FDA-approved types of devices designed to treat obesity: Gastric Bands Electrical Stimulation Systems, and Gastric Balloon Systems. Gastric Bands Lap-Band Gastric Banding System The Lap-Band System is a surgically implanted device that helps adults who are at least 18 years old eat less and lose weight. The Lap-Band consists…
Refuse to Accept Policy for 510(k)s
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Supplemental Measures to Enhance Duodenoscope Reprocessing: FDA Safety Communication
Date Issued: August 4, 2015 Audiences: Gastroenterologists Gastrointestinal surgeons Endoscopy nurses Staff working in endoscopy reprocessing units in health care facilities Infection control practitioners Personnel conducting endoscope culturing (e.g. clinical diagnostic and laboratory staff) Patients considering Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures Medical Specialties: Gastroenterology, Infection Control Device: All ERCP endoscopes (side-viewing duodenoscopes) Purpose:FDA is providing…