Regulacje i polityka gospodarcza · 27/12/1996

Advanced BionicsSUPTM Corp.; Premarket Approval of the CLARIONRegister Multi-Strategy Cochlear Implant

The Food and Drug Administration (FDA) is announcing its approval of the application by the Advanced Bionics TM Corp., Sylmar, CA, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the CLARION Multi-Strategy Cochlear Implant. After reviewing the recommendation of the Ear, Nose, and Throat Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of March 22, 1996, of the approval of the application.