PMA P100049S038
- Device
- LINX Reflux Management System
- Applicant
- Torax Medical
- PMA number
- P100049
- Supplement
- S038
- Product code
- LEI
- Decision date
- 2025-10-08
- Classification
- Gastroenterology, Urology
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Approval order statement
- for the manufacturing site change.
Current openFDA PMA Record#
- Device
- LINX Reflux Management System
- Applicant
- Torax Medical
- PMA number
- P100049
- Supplement
- S038
- Product code
- LEI
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Decision date
- 2025-10-08
- Decision code
- APPR
- Date received
- 2024-12-20
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- for the manufacturing site change.