Toray Industries (America), Inc.; Premarket Approval of the Inoue Balloon Catheter

Streszczenie

The Food and Drug Administration (FDA) is announcing its approval of the application by Toray Industries (America), Inc., New York, NY, for premarket approval, under section 515 of the Federal Food, Drug, and Cosmetic Act (the act), of the Inoue Balloon Catheter. After reviewing the recommendation of the Circulatory System Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter on June 28, 1994, of the approval of the application.