Implant, Anti-Gastroesophageal Reflux
Basic Information
- Device Name
- Implant, Anti-Gastroesophageal Reflux
- Trade Name
- Linx Reflux Management System
- PMA Number
- P100049
- Supplement Number
- S021
- 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
- March 15, 2018
- Date Received
- December 21, 2017
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for updating the precautions statement to state that use of the LINX Reflux Management System in patients with a hiatal hernia larger than 3 cm should include hiatal hernia repair to reduce the hernia to less than 3 cm and that the LINX Reflux Management System has not been evaluated in patients with an unrepaired hiatal hernia greater than 3 cm, add a hiatal hernia clinical data summary in the instructions for use, update the instructions for use section to highlight the recommendation to repair a hiatal hernia, if present, at the time of the LINX Reflux Management System implantation, and update the patient information booklet to align with the instructions for use and include 5 year clinical study results.
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 |