PMA P100049S017
- Device
- LINX REFLUX MANAGEMENT SYSTEM
- Applicant
- Torax Medical
- PMA number
- P100049
- Supplement
- S017
- Product code
- LEI
- Decision date
- 2016-05-19
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Approval order statement
- Process change is for gross leak hermeticity testing.
Current openFDA PMA Record#
- Device
- LINX REFLUX MANAGEMENT SYSTEM
- Applicant
- Torax Medical
- PMA number
- P100049
- Supplement
- S017
- Product code
- LEI
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Decision date
- 2016-05-19
- Decision code
- OK30
- Date received
- 2016-04-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Process change is for gross leak hermeticity testing.