|Trade Name||LINX REGLUX MANAGEMENT SYSTEM|
|Classification Name||implant, anti-gastroesophageal reflux|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change to the diameter for the weld balls that are at the end of the links that connect the individual linx device beads.