PMA P100049S007

Device: LINX REFLUX MANAGEMENT SYSTEM
Applicant: Torax Medical
PMA number: P100049
Supplement: S007
Product code: LEI
Decision date: 2013-12-27
Generic name: IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
Approval order statement: CHANGES TO THE FIRMS CLEANING MACHINE, CLEANING DETERGENT, MAXIMUM BEAD LOAD AND CLEANING TEMPERATURE, AND THE ADDITION OF MESHES DURING THE CLEANING AND RINSING PROCESS.

Current openFDA PMA Record#

Device: LINX REFLUX MANAGEMENT SYSTEM
Applicant: Torax Medical
PMA number: P100049
Supplement: S007
Product code: LEI
Generic name: IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
Decision date: 2013-12-27
Decision code: OK30
Date received: 2013-12-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGES TO THE FIRMS CLEANING MACHINE, CLEANING DETERGENT, MAXIMUM BEAD LOAD AND CLEANING TEMPERATURE, AND THE ADDITION OF MESHES DURING THE CLEANING AND RINSING PROCESS.