PMA P100049S009
- Device
- LINX REFLUX MANAGEMENT SYSTEM
- Applicant
- Torax Medical
- PMA number
- P100049
- Supplement
- S009
- Product code
- LEI
- Decision date
- 2014-06-11
- Classification
- Implant, Anti-gastroesophageal Reflux
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Approval order statement
- INTRODUCTION OF NEW TENSILE TESTERS TO BE USED DURING LINX DEVICE MANUFACTURING.
Current openFDA PMA Record#
- Device
- LINX REFLUX MANAGEMENT SYSTEM
- Applicant
- Torax Medical
- PMA number
- P100049
- Supplement
- S009
- Product code
- LEI
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Decision date
- 2014-06-11
- Decision code
- OK30
- Date received
- 2014-05-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- INTRODUCTION OF NEW TENSILE TESTERS TO BE USED DURING LINX DEVICE MANUFACTURING.