Zdrowie i gospodarka · 14/11/1997

NeuroControl, Corp.; Premarket Approval of Freehand System

The Food and Drug Administration (FDA) is announcing its approval of the application submitted by NeuroControl, Corp., Cleveland, OH, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the Freehand System . After reviewing the recommendation of the Neurological Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of August 15, 1997, of the approval of the application.