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DUBLIN, June 15, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN) announced today that the 510(k) Premarket Notification Application for the XEN Glaucoma Treatment System (consisting of the XEN45 Gel Stent and the XEN Injector) has been accepted for filing by the U.S. Food and Drug Administration (FDA).
FDA Approval for. AblathermÂ®. EDAP Receives FDA Approval for Ablatherm HIFU. On November 9, 2015 the Food and Drug Administration (FDA) granted full approval to EDAP Ablatherm HIFU to carry out prostate ablation treatment in the United States, using the Ablatherm Integrated Imaging device.