Device Dossier
Balloon, gastric, appetite-suppressing
Device Dossier for Balloon, gastric, appetite-suppressing (Balloon, gastric, appetite-suppressing, Class IIb, sponsor Gastro). ARTG record, intended…
- GMDN category: Balloon, gastric, appetite-suppressing
Intended purpose
The adjustable balloon system is indicated for temporary use in weight-loss therapy for overweight and obese patients who have significant health risks related to their weight and have failed to achieve and maintain weight loss with a supervised weight control program. The device is placed in the stomach and filled with saline causing it to expand into a spherical shape and act as a space filler and move freely within the stomach. The maximum placement period for the device is 12 months.