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 categoryANALYZER, PACEMAKER GENERATOR FUNCTION, TESTER, PACEMAKER ELECTRODE FUNCTION
Device ID00763000002039
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information