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Entreprise · 25/08/19941 min de lecture
Toray Industries (America), Inc.; Premarket Approval of the Inoue Balloon Catheter
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Résumé
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.
Langue originale de la source: Federal Register — Health and Human ServicesOuvrir le communiqué original →