PMA P100049S032
- Device
- LINX Reflux Management System
- Applicant
- Torax Medical
- PMA number
- P100049
- Supplement
- S032
- Product code
- LEI
- Decision date
- 2022-01-07
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Approval order statement
- Changes regarding DCOs 3872, 3893, 3876, 3753, 3792, and 3860.
Current openFDA PMA Record#
- Device
- LINX Reflux Management System
- Applicant
- Torax Medical
- PMA number
- P100049
- Supplement
- S032
- Product code
- LEI
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Decision date
- 2022-01-07
- Decision code
- OK30
- Date received
- 2021-12-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes regarding DCOs 3872, 3893, 3876, 3753, 3792, and 3860.