Implant, Anti-Gastroesophageal Reflux
Basic Information
- Device Name
- Implant, Anti-Gastroesophageal Reflux
- Trade Name
- LINX Reflux Management System
- PMA Number
- P100049
- Supplement Number
- S037
- Device Class
- FDA Class 3
- Product Code
- LEI
- Generic Name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Medical Specialty
- Unknown
- Advisory Committee
- Gastroenterology, Urology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- February 22, 2024
- Date Received
- November 27, 2023
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LEI | Implant, Anti-Gastroesophageal Reflux | FDA class 3 | Unknown |