Device Dossier

Gastrointestinal motility analysis system

Device Dossier for Gastrointestinal motility analysis system (Gastrointestinal motility analysis system, Class IIa, sponsor Medtronic). ARTG record,…

Intended purpose

This device is used in a clinical setting to obtain an estimation of the dimensions and balloon pressure within the alimentary canal. The system can also estimate distensibility and size of a stoma produced by a gastric band. The system is also used to dilate oesophageal strictures due to oesophageal surgery, primary gastro-oesophageal reflux and radiation therapy; or the Gastro-oesophageal Junction for the purpose of treating Achalasia.

TGA Public Summary