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FDA Panel Recommends Split Classifications For Cardiac Devices

Circulatory System Devices panel recommends either class II or class III designations for external counter-pulsating devices and intra-aortic balloon pumps, depending on the indication.

FDA’s Circulatory System Devices panel supported split classification for two cardiac devices, external counter-pulsating devices and intra-aortic balloon pumps, based on FDA recommendations and evaluation of previous studies.

The advisory panel met Dec. 5 in Gaithersburg, Md., to discuss the safety and efficacy of the devices, which provide noninvasive circulatory support to patients with heart conditions. Both were...

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