Device Dossier

CODMAN HAKIM Programmable Valve System - Ventriculo-peritoneal/atrial shunt

Device Dossier for CODMAN HAKIM Programmable Valve System - Ventriculo-peritoneal/atrial shunt (Ventriculo-peritoneal/atrial shunt, Class III, sponsor…

Intended purpose

The CODMAN HAKIM Programmable Valves are implantable devices that provide constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

Functional description

Programmable Valve mechanism incorporates a flat 316L stainless steel spring in which the calibration is accomplished by a combination between a pillar and micro-adjustable telescoping fulcrum. The pressure setting is noninvasively adjustable by an external programmer. Programmable pressure settings range from 30-200mmH2O. Systems may include a 14cm ventricular catheter, 120cm distal (peritoneal) catheter, SIPHONGUARD, prechamber, reservoir, adaptors, connectors, and/or valve introducers.

TGA Public Summary