LINX Reflux Management System

FDA PMAEUDAMED

Class III (US FDA PMA)

PMA P100049

by Torax Medical, Inc.

Identity

Trade Name: LINX REFLUX MANAGEMENT SYSTEM FDA PMA
Generic Name: IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX FDA PMA

Identifiers

PMA Number: P100049 FDA PMA
FDA Product Code: LEI FDA PMA

Classification

Device Class: Class III FDA PMA
Advisory Committee: Gastroenterology, Urology FDA PMA
FDA Decision: APPR Approved FDA PMA

The LINX Reflux Management System is an implantable anti-gastroesophageal reflux device designed to treat chronic gastroesophageal reflux disease (GERD). It consists of a flexible band of interlinked titanium beads with magnetic cores that augment the lower esophageal sphincter to prevent reflux.

It is indicated for patients diagnosed with GERD via abnormal pH testing who continue to have chronic symptoms despite maximum medical therapy. The device is implanted laparoscopically and is intended for long-term use. Authorisations include FDA PMA and MDD compliance.

Frequently asked questions

What is the LINX Reflux Management System made of?

The LINX Reflux Management System is composed of a flexible band of interlinked titanium beads with magnetic cores, as specified in the device description and intended to augment the lower esophageal sphincter.

Who manufactures the LINX Reflux Management System?

The LINX Reflux Management System is manufactured by Torax Medical, Inc., as stated in the MANUFACTURER field of the device data.

Is the LINX Reflux Management System indicated for patients who have not tried medication?

No, the device is indicated only for patients who continue to have chronic GERD symptoms despite maximum therapy for the treatment of reflux, as explicitly stated in the ao_statement field.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: LINX Magnetband – antireflux.info, Linx

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class III	Active
FDA PMA	United States	FDA_PMA	P100049	Class III	Active

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Manufacturer

Manufacturer: Torax Medical, Inc.
FDA Applicant: Torax Medical

Sources (2)

FDA PMA P100049 24 fields · synced Sep 18, 2026
EUDAMED 1 fields · synced Jun 1, 2026