Zdrowie i gospodarka · 15/09/2014

FDA Proposes Reclassification of External Pacemaker Pulse Generator Devices and Pacing System Analyzers

The US Food and Drug Administration (FDA) is proposing to reclassify external pacemaker pulse generator devices from a preamendments class III to a class II device, and to reclassify pacing system analyzers from a postamendments class III to a class II device, based on new information and to implement certain statutory requirements.