LAP-BAND AP Adjustable Gastric Banding System with RapidPort EZ

Apollo Endosurgery, Inc.

Gastric band

The purpose of this notification is to inform you that the MRI information section of the LAP-BAND DFU and the LAP-BAND Patient ID Card were updated in July 2019 and January 2020 respectively, to remove the use of outdated MRI terminology and to state that the implantable portion of the system is “MRI Conditional.” Additionally, the DFU was updated to specify under what conditions a LAP-BAND patient can safely undergo an MRI (previously this information was available upon request). Specific changes made to the aforementioned DFU are described below. The same changes have been made to each of the two Directions for Use leaflets.