PMA P100049S029
- Device
- LINX Reflux Management System
- Applicant
- Torax Medical
- Product code
- LEI
- Decision date
- 2022-08-26
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Approval order statement
- Approval for the qualification of a new supplier to manufacture the washer, bead case-female, bead case-male and clasp case.
Current openFDA PMA Record#
- Device
- LINX Reflux Management System
- Applicant
- Torax Medical
- PMA number
- P100049
- Supplement
- S029
- Product code
- LEI
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Decision date
- 2022-08-26
- Decision code
- APPR
- Date received
- 2021-01-12
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the qualification of a new supplier to manufacture the washer, bead case-female, bead case-male and clasp case.