PMA P100049S040
- Device
- LINX™ Reflux Management System
- Applicant
- Torax Medical
- PMA number
- P100049
- Supplement
- S040
- Product code
- LEI
- Decision date
- 2026-01-16
- Classification
- Gastroenterology, Urology
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Approval order statement
- replacement of microscope and micrometer to perform inspections of incoming components
Current openFDA PMA Record#
- Device
- LINX™ Reflux Management System
- Applicant
- Torax Medical
- PMA number
- P100049
- Supplement
- S040
- Product code
- LEI
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Decision date
- 2026-01-16
- Decision code
- OK30
- Date received
- 2025-12-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- replacement of microscope and micrometer to perform inspections of incoming components