|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||LINX REFLUX MANAGEMENT SYSTEM|
|Classification Name||implant, anti-gastroesophageal reflux|
|Supplement Type|| Special Supplement|
|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.