Kensey Nash Corp.; Premarket Approval of the Angio- SealSUPTM/SUP Hemostatic Puncture Closure Device

Streszczenie

The Food and Drug Administration (FDA) is announcing its approval of the application by Kensey Nash Corp., Exton, PA, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the Angio-Seal TM Hemostatic Puncture Closure Device. After reviewing the recommendation of the Circulatory System Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of September 30, 1996, of the approval of the application.