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