PMA P100049S020
- Device
- Linx Reflux Management System
- Applicant
- Torax Medical
- PMA number
- P100049
- Supplement
- S020
- Product code
- LEI
- Decision date
- 2018-01-29
- Classification
- Implant, Anti-gastroesophageal Reflux
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Linx Reflux Management System
- Applicant
- Torax Medical
- PMA number
- P100049
- Supplement
- S020
- Product code
- LEI
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Decision date
- 2018-01-29
- Decision code
- APPR
- Date received
- 2017-11-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.