Tag: external pacemaker pulse generator

19
Apr

FDA Reclassifies Cardiovascular EPPG and PSA Devices into Class II

FDA Final Order for Medical Device Reclassification Reclassification of Cardiovascular Devices External Pacemaker Pulse Generator and Pacing System Analyzers 21 CFR Part 870 FDA issues Final Order, effective as of April 18, 2016, to reclassify external pacemaker pulse generator (EPPG) as well as to create a separate classification regulation for pacing system analyzers (PSAs) devices and reclassify PSA devices into

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