|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||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Changes to the firms cleaning machine, cleaning detergent, maximum bead load and cleaning temperature, and the addition of meshes during the cleaning and rinsing process.