|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM|
|Classification Name||implant, intragastric for morbid obesity|
|Generic Name|| gastric band|
|Supplement Type|| Special Supplement|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to modify the instructions for use to add ¿data from a post-approval study showed an estimated explant rate of 6. 5% per year over the first five years following implantation¿ to the adverse events section.