|Trade Name||REALIZE ADJUSTABLE GASTRIC BAND|
|Classification Name||implant, intragastric for morbid obesity|
|Applicant||ETHICON ENDO-SURGERY, INC.|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to modify the injection port torque inspection procedure by replacing pre-and post-torque test inspections with visual and functional inspections and modify three injection port manufacturing documents to incorporate the changes in the torque inspection procedure and to improve clarity of instructions.