FDA Approves FemcareSUPTM Ltd.'s Filshie Clip SystemSUPTM (Mark VI) for Pre-Market Approval

Summary

The FDA has approved FemcareSUPTM Ltd.'s application for premarket approval of the Filshie Clip SystemSUPTM (Mark VI) under the Federal Food, Drug, and Cosmetic Act, following the recommendation of the Obstetrics and Gynecology Devices Panel. The approval was notified to the applicant by the FDA's Center for Devices and Radiological Health on September 5, 1996.