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Zdrowie i gospodarka · 06/04/2015

FDA Classifies Urethral Insert with Pump for Bladder Drainage into Class II with Special Controls

The FDA has classified the urethral insert with pump for bladder drainage into Class II, requiring special controls to ensure the device's safety and effectiveness, following a review of its medical benefits and risks.

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