Premarket Approval (PMA)

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.

• 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: S035
• Date Received: 11/14/2023
• Decision Date: 12/14/2023
• Product Code: LEI
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
for the change of an internal inspection process to an equivalent inspection process at their magnet component supplier.