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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLINX Reflux Management System
Generic NameIMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
ApplicantTORAX MEDICAL
4545 Creek Rd
Cincinnati, OH 45242
PMA NumberP100049
Supplement NumberS037
Date Received11/27/2023
Decision Date02/22/2024
Product Code LEI 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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.
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