LINX Reflux Management System
FDA premarket approval P100049/S037 · decided 2024-02-22
Approval details
- PMA number
- P100049
- Supplement
- S037
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LINX Reflux Management System
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Applicant
- Torax Medical
- Date received
- 2023-11-27
- Decision date
- 2024-02-22
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- LEI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Cincinnati, OH
- 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 describe
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