Zdrowie i gospodarka · 08/06/2015

FDA Reclassifies Nonroller-Type Cardiopulmonary Bypass Blood Pumps for Cardiopulmonary and Circulatory Bypass

The US Food and Drug Administration (FDA) has issued a final order to reclassify nonroller-type cardiopulmonary bypass blood pumps, which are used for temporary ventricular support, from a preamendments class III device to a class II device with special controls, requiring manufacturers to submit a premarket approval application (PMA) for these devices.