PMA P100049S006
- Device
- LINX REFLUX MANAGEMENT SYSTEM
- Applicant
- Torax Medical
- PMA number
- P100049
- Supplement
- S006
- Product code
- LEI
- Decision date
- 2013-12-19
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Approval order statement
- APPROVAL FOR AN UPDATE TO THE LABELING FOR THE LINX DEVICE REGARDING EXPOSURE TO MRI SCANS.
Current openFDA PMA Record#
- Device
- LINX REFLUX MANAGEMENT SYSTEM
- Applicant
- Torax Medical
- PMA number
- P100049
- Supplement
- S006
- Product code
- LEI
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Decision date
- 2013-12-19
- Decision code
- APPR
- Date received
- 2013-05-07
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR AN UPDATE TO THE LABELING FOR THE LINX DEVICE REGARDING EXPOSURE TO MRI SCANS.