Device typeImplantable cardiac device management application software: An application software program intended to be used in the management of an implantable cardiac device (e.g., monitor, pulse generator, pacemaker, defibrillator) by enabling computer-assisted functionality typically in one or more of the following areas: device programming; device function analysis; data extraction, storage, analysis and/or transfer; and clinical consultation/intervention planning. Depending on the functionality, it can run on dedicated hardware, an off-the-shelf computer (e.g., tablet, smartphone), or web-based servers.
FDA categoryAcute coronary syndrome event detector
Device ID00850012625063
Catalog number0204-2100-075#P16
MRI safetyLabeling does not contain MRI Safety Information