|
Device | LINX Reflux Management System |
Generic Name | IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX |
Applicant | TORAX MEDICAL 4545 Creek Rd Cincinnati, OH 45242 |
PMA Number | P100049 |
Supplement Number | S033 |
Date Received | 04/08/2022 |
Decision Date | 10/04/2022 |
Product Code |
LEI |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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. |