PMA P100049S012

Device: LINX REFLUX MANAGEMENT SYSTEM
Applicant: Torax Medical
PMA number: P100049
Supplement: S012
Product code: LEI
Decision date: 2015-04-21
Generic name: IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
Approval order statement: 1) UTILIZATION OF AN IN-HOUSE LASER WELDING SYSTEM;2) UTILIZATION OF IN-HOUSE HERMETICITY TESTING SYSTEMS;3) UTILIZATION OF AN IN-HOUSE WIRE CUTTING PROCESS;4) UTILIZATION OF AN IN-HOUSE PNEUMATIC WIRE LINK BENDING PROCESS; AND5) MODIFICATION OF AN INCOMING INSPECTION ACCEPTANCE CRITERION FOR ONE OF THE MAGNET TYPES.

Current openFDA PMA Record#

Device: LINX REFLUX MANAGEMENT SYSTEM
Applicant: Torax Medical
PMA number: P100049
Supplement: S012
Product code: LEI
Generic name: IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
Decision date: 2015-04-21
Decision code: OK30
Date received: 2015-03-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: 1) UTILIZATION OF AN IN-HOUSE LASER WELDING SYSTEM;2) UTILIZATION OF IN-HOUSE HERMETICITY TESTING SYSTEMS;3) UTILIZATION OF AN IN-HOUSE WIRE CUTTING PROCESS;4) UTILIZATION OF AN IN-HOUSE PNEUMATIC WIRE LINK BENDING PROCESS; AND5) MODIFICATION OF AN INCOMING INSPECTION ACCEPTANCE CRITERION FOR ONE OF THE MAGNET TYPES.