PMA P100049S005

Device
LINX REFLUX MANAGEMENT SYSTEM
Applicant
Torax Medical
PMA number
P100049
Supplement
S005
Product code
LEI
Decision date
2013-04-17
Generic name
IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
Approval order statement
UPDATE IN MANUFACTURING PROCESS.

Current openFDA PMA Record#

Device
LINX REFLUX MANAGEMENT SYSTEM
Applicant
Torax Medical
PMA number
P100049
Supplement
S005
Product code
LEI
Generic name
IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
Decision date
2013-04-17
Decision code
OK30
Date received
2013-03-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
UPDATE IN MANUFACTURING PROCESS.