|
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 | S004 |
Date Received | 06/19/2012 |
Decision Date | 03/07/2013 |
Product Code |
LEI |
Advisory Committee |
Gastroenterology/Urology |
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 A NEW ESOPHAGUS SIZING TOOL THAT WILL BE USED DURING THE IMPLANT PROCEDURE. |