FemcareSUPTM Ltd.; Premarket Approval of Filshie Clip SystemSUPTM (Mark VI)

概要

The Food and Drug Administration (FDA) is announcing its approval of the application submitted by Family Health International, Research Triangle Park, NC, U.S. Representative for Femcare TM Ltd., Nottingham, U.K., for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the Filshie Clip System TM (Mark VI). After reviewing the recommendation of the Obstetrics and Gynecology Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of September 5, 1996, of the approval of the application.