Avanta Orthopaedics Corp.; Premarket Approval of Braun-Cutter Trapezo-metacarpal prosthesis

Streszczenie

The Food and Drug Administration (FDA) is announcing its approval of the application by Avanta Orthopaedics Corp., San Diego, CA, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the Braun-Cutter Trapezo-metacarpal Prosthesis. After reviewing the recommendation of the Orthopedics and Rehabilitation Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of June 19, 1997, of the approval of the application. DATES: Petitions for administrative review by October 23, 1997.