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Zdrowie i gospodarka · 30.06.1998

Medical Devices; Retention of Three Preamendment Class III Devices in Class III

The Food and Drug Administration (FDA) is retaining the following three preamendments class III devices in class III: Lung water monitor, powered vaginal muscle stimulator for therapeutic use, and stair-climbing wheelchair. The agency is taking this action because insufficient information exists to determine that special controls would provide reasonable assurance of their safety and effectiveness, and/or these devices present a potential unreasonable risk of illness or injury.

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