Advanced Bionics Halts Positioner Shipments In Precautionary Measure
This article was originally published in The Gray Sheet
Executive Summary
Advanced Bionics has submitted a PMA supplement for approval to implant the company's Clarion cochlear implant without the accompanying electrode positioner
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Recalled Cochlear Implant Positioner Increases Meningitis Risk – NEJM Study
Advanced Bionics' decision to remove the electrode positioner from its Clarion cochlear implants last summer is supported by a study in the July 31 issue of The New England Journal of Medicine
Recalled Cochlear Implant Positioner Increases Meningitis Risk – NEJM Study
Advanced Bionics' decision to remove the electrode positioner from its Clarion cochlear implants last summer is supported by a study in the July 31 issue of The New England Journal of Medicine
International News In Brief
EUDAMED: Competent authorities will be able to access adverse event reports throughout Europe by year-end in the first phase of the European Database on Medical Devices. Notified bodies and other parties, however, likely will not have access until 2004, according to the European Commission (1"The Gray Sheet" Feb. 10, 2003, p. 26)...