Zdrowie i gospodarka · 23/09/1997

Advanced BionicsSUPTM/SUP Corp.; Premarket Approval of CLARIONRegister Multi-StrategySUPTM/SUP Cochlear Implant

The Food and Drug Administration (FDA) is announcing its approval of the application by Advanced Bionics TM Corp., Sylmar, CA, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the CLARION Multi- Strategy TM 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 June 26, 1997, of the approval of the application.