> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Obalon PMA Supplement OK’d for Obesity Device Inflator
- URL: https://www.fdaweb.com/obalon-pma-supplement-okd-for-obesity-device-inflator/
- Published: 2018-09-27T12:00:00.000Z
- Updated: 2026-09-15T00:34:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142468

FDA has approved an Obalon Therapeutics PMA supplement for the Obalon Touch Inflation System for use in inflating the Obalon Balloon, a swallowable gas-filled intragastric balloon system for treating obesity. The inflation device is intended to be marketed with the Obalon Navigation System, which is designed to eliminate the need for X-ray imaging during balloon placement. A PMA supplement for the navigation component was filed earlier this year and is still pending a decision by the agency.