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Advanced Bionics launches Clarion 1.2 cochlear implant in U.S. following FDA approval Aug. 2.

This article was originally published in The Gray Sheet

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Executive Summary

ADVANCED BIONICS CLARION 1.2 COCHLEAR IMPLANT SHIPMENTS BEGIN following FDA approval Aug. 2 of a premarket approval application supplement for the device. A larger version of the device, the Clarion 1.0, was approved on March 29 ("The Gray Sheet" April 15, p. 10), however, the company delayed a full-scale launch until receiving a green light from the agency to commercialize the 1.2 model. The firm is no longer manufacturing the first generation device.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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