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PMA P100049S019

Device
LINX REFLUX MANAGEMENT SYSTEM
Applicant
Torax Medical
PMA number
P100049
Supplement
S019
Product code
LEI
Decision date
2017-01-12
Generic name
IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
Approval order statement
Utilization of an additional, higher capacity laser welding system and to maintain 100% individual link length inspection conducted at final device inspection, but remove all in-process assembly weld link length inspections and the overall device length final inspection.

Current openFDA PMA Record#

Device
LINX REFLUX MANAGEMENT SYSTEM
Applicant
Torax Medical
PMA number
P100049
Supplement
S019
Product code
LEI
Generic name
IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
Decision date
2017-01-12
Decision code
OK30
Date received
2016-12-15
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Utilization of an additional, higher capacity laser welding system and to maintain 100% individual link length inspection conducted at final device inspection, but remove all in-process assembly weld link length inspections and the overall device length final inspection.