PMA P100049S036
- Device
- LINX Reflux Management System
- Applicant
- Torax Medical
- PMA number
- P100049
- Supplement
- S036
- Product code
- LEI
- Decision date
- 2023-12-19
- Classification
- Gastroenterology, Urology
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Approval order statement
- removal of an inspection procedure and update to a cleaning procedure in relation to the wire specification.
Current openFDA PMA Record#
- Device
- LINX Reflux Management System
- Applicant
- Torax Medical
- PMA number
- P100049
- Supplement
- S036
- Product code
- LEI
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Decision date
- 2023-12-19
- Decision code
- OK30
- Date received
- 2023-11-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- removal of an inspection procedure and update to a cleaning procedure in relation to the wire specification.