|
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 | S015 |
Date Received | 12/08/2015 |
Decision Date | 03/02/2016 |
Product Code |
LEI |
Advisory Committee |
Gastroenterology/Urology |
Clinical Trials | NCT00776997
|
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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. |