|
Device | LINX Reflux Management System |
Generic Name | IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX |
Applicant | TORAX MEDICAL 4545 Creek Rd Cincinnati, OH 45242 |
PMA Number | P100049 |
Supplement Number | S037 |
Date Received | 11/27/2023 |
Decision Date | 02/22/2024 |
Product Code |
LEI |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE FOLLOWING LABELING UPDATES:1) Removal of Barrett's Esophagus (BE) from a precaution statement in the instructions for use. LINX has not been demonstrated to be an effective treatment that leads to BE regression or prevention of progression to cancer. As such, patients with BE who are treated with LINX for management of GERD symptoms should consult with their physician for continued treatment of BE (including PPI use).2) Addition of a "Clinical Data Summary" section that describes a single observational study that supports safe use of the LINX device to treat GERD symptoms in patients with known BE3) Updates to the Patient Information Booklet to align with changes to the instructions for use. |