|Trade Name||BIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM|
|Classification Name||implant, intragastric for morbid obesity|
|Generic Name||adjustable gastric banding system|
|Supplement Type||normal 180 day track|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the following modifications to the lap-band adustable gastric banding (lagb) system: 1) introduction of a redesigned access port (access port ii); 2) replace the calibration tube (calibration tube i) currently provided in the lagb) system with a redesigned calibration tube (calibration tube ii); and 3) introduction of 2" access port needles to be sold as an accessory item. In addition to being sold as components of the lagb system, both the access port ii and the calibration tube ii will be sold as separate accessories.