Device Dossier

Implantation Kit - Stereotactic surgery system, neurological

Device Dossier for Implantation Kit - Stereotactic surgery system, neurological (Stereotactic surgery system, neurological, Class IIa, sponsor Surgical…

Intended purpose

The implantation kit is used under stereotactic conditions to enable the positioning of Microdeep depth electrodes or the conduct of biopsies in the brain. Items in the implantation kit are to be used for just a few minutes (temporary use limited to 60 minutes in all cases), and a single implantation kit may be used to position several electrodes / perform several biopsies during the course of a single surgical procedure on a single patient.

TGA Public Summary