PMA P100049S014

Device
LINX REFLUX MANAGEMENT SYSTEM
Applicant
Torax Medical
PMA number
P100049
Supplement
S014
Product code
LEI
Decision date
2015-07-24
Generic name
IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
Approval order statement
IMPLEMENT AN UPGRADED, AUTOMATED WIRE LINK CUTTER.

Current openFDA PMA Record#

Device
LINX REFLUX MANAGEMENT SYSTEM
Applicant
Torax Medical
PMA number
P100049
Supplement
S014
Product code
LEI
Generic name
IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
Decision date
2015-07-24
Decision code
OK30
Date received
2015-06-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
IMPLEMENT AN UPGRADED, AUTOMATED WIRE LINK CUTTER.