PMA P100049S037

Device: LINX Reflux Management System
Applicant: Torax Medical
PMA number: P100049
Supplement: S037
Product code: LEI
Decision date: 2024-02-22
Classification: Gastroenterology, Urology
Generic name: IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
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.

Current openFDA PMA Record#

Device: LINX Reflux Management System
Applicant: Torax Medical
PMA number: P100049
Supplement: S037
Product code: LEI
Generic name: IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
Decision date: 2024-02-22
Decision code: APPR
Date received: 2023-11-27
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.