PMA P100049S028

Device
Linx Reflux Management System
Applicant
Torax Medical
PMA number
P100049
Supplement
S028
Product code
LEI
Decision date
2019-12-10
Generic name
IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
Approval order statement
Implementation of a new automatic measuring system and measuring test method.

Current openFDA PMA Record#

Device
Linx Reflux Management System
Applicant
Torax Medical
PMA number
P100049
Supplement
S028
Product code
LEI
Generic name
IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
Decision date
2019-12-10
Decision code
OK30
Date received
2019-10-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of a new automatic measuring system and measuring test method.