Device Dossier

Balloon, gastric, appetite-suppressing

Device Dossier for Balloon, gastric, appetite-suppressing (Balloon, gastric, appetite-suppressing, Class IIb, sponsor Emergo). ARTG record, intended…

Intended purpose

This is a component of a Gastric Balloon System. This practice capsule is a vegetarian, non-animal derived, degradable capsule that is approximately the same size and weight as the device within the Gastric Balloon System. The practice capsule may be offered as an option to the patient before the device is administered, to familiarize the patient with the swallowing experience.

TGA Public Summary