PMA P100049S035
- Device
- LINX Reflux Management System
- Applicant
- Torax Medical
- PMA number
- P100049
- Supplement
- S035
- Product code
- LEI
- Decision date
- 2023-12-14
- Classification
- Gastroenterology, Urology
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Approval order statement
- for the change of an internal inspection process to an equivalent inspection process at their magnet component supplier.
Current openFDA PMA Record#
- Device
- LINX Reflux Management System
- Applicant
- Torax Medical
- PMA number
- P100049
- Supplement
- S035
- Product code
- LEI
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Decision date
- 2023-12-14
- Decision code
- OK30
- Date received
- 2023-11-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- for the change of an internal inspection process to an equivalent inspection process at their magnet component supplier.