Urgent Safety Notice for the Obalon Inflation System, Obalon Therapeutics, Inc.
2013.12.10
Product group Non-active implants - special implants
Reference 05585/13
Obalon Therapeutics, Inc. released an urgent Field Safety Notice informing that the Obalon Inflation System must not be used at elevations higher than 660 meters (2,165 feet) above sea level.