PMA P100049S008
- Device
- LINX REGLUX MANAGEMENT SYSTEM
- Applicant
- Torax Medical
- PMA number
- P100049
- Supplement
- S008
- Product code
- LEI
- Decision date
- 2014-04-09
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Approval order statement
- CHANGE TO THE DIAMETER FOR THE WELD BALLS THAT ARE AT THE END OF THE LINKS THAT CONNECT THE INDIVIDUAL LINX DEVICE BEADS.
Current openFDA PMA Record#
- Device
- LINX REGLUX MANAGEMENT SYSTEM
- Applicant
- Torax Medical
- PMA number
- P100049
- Supplement
- S008
- Product code
- LEI
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Decision date
- 2014-04-09
- Decision code
- OK30
- Date received
- 2014-03-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE DIAMETER FOR THE WELD BALLS THAT ARE AT THE END OF THE LINKS THAT CONNECT THE INDIVIDUAL LINX DEVICE BEADS.