Device Dossier

Clinician Programmer with Bionic Navigator Software (SC-7150-4) - Computer interface

Device Dossier for Clinician Programmer with Bionic Navigator Software (SC-7150-4) - Computer interface (Computer interface, Class III, sponsor Boston…

Intended purpose

The Clinician Programmer with Bionic Navigator Software is used to program an implantable pulse generator which is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain.

Functional description

The Clinician Programmer with Bionic Navigator Software communicates with the stimulator using an infrared link to the Remote Control. Programs can be loaded to the programmer for previewing, activating and changing stimulation patterns. It is also used to identify both pain and paresthesia areas using a visual representation of anatomical coverage areas in relation to the patient

TGA Public Summary