PMA P100049S010
- Device
- LINX REFLUX MANAGEMENT SYSTEM
- Applicant
- Torax Medical
- PMA number
- P100049
- Supplement
- S010
- Product code
- LEI
- Decision date
- 2014-07-22
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Approval order statement
- APPROVAL FOR LABELING ALTERATIONS INCLUDING ADVERSE EVENT INFORMATION ABOUT EROSION OF THE LINX DEVICE, CLARIFICATIONS OR CONTRAINDICATIONS REGARDING NICKEL, WARNINGS REGARDING STORAGE AND USE ABOVE 60 DEGREES C, ADDITIONAL POTENTIAL RISK OF SALIVA/MUCUS BUILD-UP, AND DIRECTIONS WHICH ADD THE REMOVAL OF SUTURES AFTER THE CLASP ENDS ARE FULLY ENGAGED.
Current openFDA PMA Record#
- Device
- LINX REFLUX MANAGEMENT SYSTEM
- Applicant
- Torax Medical
- PMA number
- P100049
- Supplement
- S010
- Product code
- LEI
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Decision date
- 2014-07-22
- Decision code
- APPR
- Date received
- 2014-06-23
- Supplement type
- Special (Immediate Track)
- Approval order statement
- APPROVAL FOR LABELING ALTERATIONS INCLUDING ADVERSE EVENT INFORMATION ABOUT EROSION OF THE LINX DEVICE, CLARIFICATIONS OR CONTRAINDICATIONS REGARDING NICKEL, WARNINGS REGARDING STORAGE AND USE ABOVE 60 DEGREES C, ADDITIONAL POTENTIAL RISK OF SALIVA/MUCUS BUILD-UP, AND DIRECTIONS WHICH ADD THE REMOVAL OF SUTURES AFTER THE CLASP ENDS ARE FULLY ENGAGED.