PMA P100049S025
- Device
- LINX Reflux Management System
- Applicant
- Torax Medical
- PMA number
- P100049
- Supplement
- S025
- Product code
- LEI
- Decision date
- 2018-11-09
- Classification
- Implant, Anti-gastroesophageal Reflux
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Approval order statement
- Adding a step to the incoming inspection process for the washers and male bead cases of the LINX Reflux Management System.
Current openFDA PMA Record#
- Device
- LINX Reflux Management System
- Applicant
- Torax Medical
- PMA number
- P100049
- Supplement
- S025
- Product code
- LEI
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Decision date
- 2018-11-09
- Decision code
- OK30
- Date received
- 2018-10-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adding a step to the incoming inspection process for the washers and male bead cases of the LINX Reflux Management System.