PMA P100049S004
- Device
- LINX REFLUX MANAGEMENT SYSTEM
- Applicant
- Torax Medical
- PMA number
- P100049
- Supplement
- S004
- Product code
- LEI
- Decision date
- 2013-03-07
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Approval order statement
- APPROVAL FOR A NEW ESOPHAGUS SIZING TOOL THAT WILL BE USED DURING THE IMPLANT PROCEDURE.
Current openFDA PMA Record#
- Device
- LINX REFLUX MANAGEMENT SYSTEM
- Applicant
- Torax Medical
- PMA number
- P100049
- Supplement
- S004
- Product code
- LEI
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Decision date
- 2013-03-07
- Decision code
- APPR
- Date received
- 2012-06-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A NEW ESOPHAGUS SIZING TOOL THAT WILL BE USED DURING THE IMPLANT PROCEDURE.