Zdrowie i gospodarka · 21/05/2013

FDA Proposes Changes to External Counter-Pulsating Devices for Chronic Stable Angina Treatment

The FDA is proposing to reclassify external counter-pulsating devices for treating chronic stable angina that is resistant to medical therapy and lacks revascularization options, from a Class III device to a Class II device with special controls, and requires premarket approval for other intended uses.