Device Dossier
M.scio Flat Implant - Cerebrospinal fluid shunt sensor/reservoir
Device Dossier for M.scio Flat Implant - Cerebrospinal fluid shunt sensor/reservoir (Cerebrospinal fluid shunt sensor/reservoir, Class III, sponsor B…
- GMDN category: Cerebrospinal fluid shunt sensor/reservoir
- Sponsor: B Braun
Intended purpose
It is used for intracranial pressure measurement within the cerebrospinal fluid (CSF); it measures intracranial pressure, diverts CSF to manage elevated pressure. It is not designed for puncture or external infusion/injection/drainage.
Functional description
The M.scio Flat implant is a ICP active implantable medical device designed for integration into a shunt. It is used when a patient’s skull anatomy lacks sufficient space. The measuring cell, housed in the reservoir, has a pressure-sensitive membrane facing the ventricle. Measurement data is collected electronically, read out telemetrically, displayed on the Reader Unit Set, and stored on an SD card for analysis.