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Zdrowie i gospodarka · 2.12.1996

UroMed Corp.; Premarket Approval of RelianceRegister Urinary Control Insert and Sizing Device

The Food and Drug Administration (FDA) is announcing its approval of the application by UroMed Corp., Needham, MA, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the Reliance Urinary Control Insert and Sizing Device. After reviewing the recommendation of the Gastroenterology and Urology Devices Advisory Panel, FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of August 16, 1996, of the approval of the application.

Source: Federal Register — Food and Drug AdministrationOpen original release →