Device Dossier

StrataMR II Shunt Kit - Valve, hydrocephalic

Device Dossier for StrataMR II Shunt Kit - Valve, hydrocephalic (Valve, hydrocephalic, Class III, sponsor Medtronic). ARTG record, intended purpose, GMDN…

Intended purpose

The StrataMR™ ll Shunt Kits are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design enables the physician to non-invasively adjust valve pressure/performance level pre- and post-implantation by using magnetic adjustment tools without the need for radiographic confirmation.

Functional description

The StrataMR II Shunt Kit consists of the StrataMR II Valve, a ventricular catheter and a peritoneal catheter. These devices are designed for use in shunting cerebrospinal fluid from the ventricles of the brain into the right atrium of the heart or to the peritoneal cavity.

TGA Public Summary