|Trade Name||LINX REFLUX MANAGEMENT SYSTEM|
|Classification Name||implant, anti-gastroesophageal reflux|
|Generic Name||implant, anti-gastroesophageal reflux|
|Supplement Type||special (immediate track)|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for labeling alterations including adverse event information about erosion of the linx device, clarifications or contraindications regarding nickel, warnings regarding storage and use above 60 degrees c, additional potential risk of saliva/mucus build-up, and directions which add the removal of sutures after the clasp ends are fully engaged.