Device Dossier
Neurophysiologic monitoring system
Device Dossier for Neurophysiologic monitoring system (Neurophysiologic monitoring system, Class IIa, sponsor Nuvasive (Aust/NZ)). ARTG record, intended…
- GMDN category: Neurophysiologic monitoring system
Intended purpose
The NV and Pulse systems are intended for intraoperative neurophysiologic monitoring during spinal surgery. The device provides information directly to the surgeon to help assess a patient's neurophysiologic status. NV and Pulse provide this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), transcranial motor evoked potential (TCMEP), somatosensory evoked potential (SSEP) or Motor Evoked Potential (MEP) responses of nerves.