PMA P100049S013

Device
LINX REFLUX MANAGEMENT SYSTEM
Applicant
Torax Medical
PMA number
P100049
Supplement
S013
Product code
LEI
Decision date
2015-07-20
Generic name
IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
Approval order statement
IMPLEMENTATION OF AN UPGRADED MEASUREMENT SYSTEM TO FACILITATE RECEIVING/INSPECTION AND VARIOUS R&D PROJECTS.

Current openFDA PMA Record#

Device
LINX REFLUX MANAGEMENT SYSTEM
Applicant
Torax Medical
PMA number
P100049
Supplement
S013
Product code
LEI
Generic name
IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
Decision date
2015-07-20
Decision code
OK30
Date received
2015-06-23
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
IMPLEMENTATION OF AN UPGRADED MEASUREMENT SYSTEM TO FACILITATE RECEIVING/INSPECTION AND VARIOUS R&D PROJECTS.