|Trade Name||REALIZE ADJUSTABLE GASTRIC BAND-C|
|Classification Name||implant, intragastric for morbid obesity|
|Applicant||ETHICON ENDO-SURGERY, INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Addition of an in-house manufacturing site for a device component as well as changes to several manufacturing steps.