Zdrowie i gospodarka · 19/06/2013

FDA Proposes Reclassification of Intra-Aortic Balloon and Control Systems for Acute Coronary Syndrome and Heart Failure

The FDA is proposing to reclassify intra-aortic balloon and control systems for use in acute coronary syndrome, cardiac surgery, and heart failure from a preamendments class III device to a class II device with special controls, requiring premarket approval for certain uses.