PMA P100049S026
- Device
- LINX Reflux Mnagement System
- Applicant
- Torax Medical
- PMA number
- P100049
- Supplement
- S026
- Product code
- LEI
- Decision date
- 2019-07-15
- Classification
- Implant, Anti-gastroesophageal Reflux
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Approval order statement
- Implementation of new packaging equipment and packaging testing.
Current openFDA PMA Record#
- Device
- LINX Reflux Mnagement System
- Applicant
- Torax Medical
- PMA number
- P100049
- Supplement
- S026
- Product code
- LEI
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Decision date
- 2019-07-15
- Decision code
- OK30
- Date received
- 2019-06-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of new packaging equipment and packaging testing.