PMA P100049S031

Device
LINX Reflux Management System
Applicant
Torax Medical
PMA number
P100049
Supplement
S031
Product code
LEI
Decision date
2022-01-07
Generic name
IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
Approval order statement
Changes regarding DCO 3814 & DCO 3780.

Current openFDA PMA Record#

Device
LINX Reflux Management System
Applicant
Torax Medical
PMA number
P100049
Supplement
S031
Product code
LEI
Generic name
IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
Decision date
2022-01-07
Decision code
OK30
Date received
2021-12-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Changes regarding DCO 3814 & DCO 3780.