Advanced Bionics Clarion cochlear implant slated for FDA panel review in July.
This article was originally published in The Gray Sheet
Executive Summary
ADVANCED BIONICS CLARION COCHLEAR IMPLANT PMA SLATED FOR JULY 21 REVIEW by FDA's Ear, Nose and Throat Devices Advisory Panel at a meeting in Gaithersburg, Maryland, according to the firm. In support of a premarket approval application for the device, Advanced Bionics will present safety data on a cohort of 273 patients from U.S. and overseas clinical trials and effectiveness data on 68 U.S. subjects followed 6 months post-implant. The firm submitted the PMA to the agency in June 1994.