Genzyme Corp.; Premarket Approval of SeprafilmSUPTM Bioresorbable Membrane

Streszczenie

The Food and Drug Administration (FDA) is announcing its approval of the application by Genzyme Corp., Cambridge, MA, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of Seprafilm TM Bioresorbable Membrane. After reviewing the recommendation of the General and Plastic Surgery Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of August 12, 1996, of the approval of the application.