Regulacje i polityka gospodarcza · 09/10/1996

EDAP Technomed Group (U.S.A.), Inc.; Premarket Approval of ProstatronSUPTM

The Food and Drug Administration (FDA) is announcing its approval of the application by the EDAP Technomed Group (U.S.A), Inc., Cambridge, MA, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the Prostatron TM. After reviewing the recommendation of the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee, FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of May 3, 1996, of the approval of the application.