PMA P100049S033

Device: LINX Reflux Management System
Applicant: Torax Medical
Product code: LEI
Decision date: 2022-10-04
Generic name: IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
Approval order statement: Approval for the following labeling updates: 1) inclusion of final post-approval study results; 2) addition of a precaution based on RELIEF study results; 3) addition of “swallow-induced syncope to the list of adverse events; and 4) revised registered/trademark status.

Current openFDA PMA Record#

Device: LINX Reflux Management System
Applicant: Torax Medical
PMA number: P100049
Supplement: S033
Product code: LEI
Generic name: IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
Decision date: 2022-10-04
Decision code: APPR
Date received: 2022-04-08
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the following labeling updates: 1) inclusion of final post-approval study results; 2) addition of a precaution based on RELIEF study results; 3) addition of “swallow-induced syncope to the list of adverse events; and 4) revised registered/trademark status.