Device Dossier

CareLink SmartSync Device Manager System - Cardiac pulse generator programmer

Device Dossier for CareLink SmartSync Device Manager System - Cardiac pulse generator programmer (Cardiac pulse generator programmer, Class III, sponsor…

Intended purpose

The device manager system is intended to be used to interrogate and program Medtronic implanted devices and start a cardiac lead analysis session during Medtronic heart device implant or invasive troubleshooting.

Functional description

The CareLink SmartSync Device Manager System includes the following components: CareLink SmartSync Base (Sirius Base Station/Base), Patient Connector, CareLink SmartSync Device Manager App (device manager app), CareLink SmartSync PSA App (Analyzer/Analyzer Tools) and CareLink SmartSync Implantable Device App (implantable device app).

TGA Public Summary