PMA P100049S015

Device: LINX REFLUX MANAGEMENT SYSTEM
Applicant: Torax Medical
PMA number: P100049
Supplement: S015
Product code: LEI
Decision date: 2016-03-02
Generic name: IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
Approval order statement: Approval for updating the labeling with safety and effectiveness data out to five (5) years for the pivotal trial cohort extended follow-up that has been completed and modify the Indications For Use.

Current openFDA PMA Record#

Device: LINX REFLUX MANAGEMENT SYSTEM
Applicant: Torax Medical
PMA number: P100049
Supplement: S015
Product code: LEI
Generic name: IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
Decision date: 2016-03-02
Decision code: APPR
Date received: 2015-12-08
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for updating the labeling with safety and effectiveness data out to five (5) years for the pivotal trial cohort extended follow-up that has been completed and modify the Indications For Use.