|
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 | S012 |
Date Received | 03/25/2015 |
Decision Date | 04/21/2015 |
Product Code |
LEI |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 1) UTILIZATION OF AN IN-HOUSE LASER WELDING SYSTEM;2) UTILIZATION OF IN-HOUSE HERMETICITY TESTING SYSTEMS;3) UTILIZATION OF AN IN-HOUSE WIRE CUTTING PROCESS;4) UTILIZATION OF AN IN-HOUSE PNEUMATIC WIRE LINK BENDING PROCESS; AND5) MODIFICATION OF AN INCOMING INSPECTION ACCEPTANCE CRITERION FOR ONE OF THE MAGNET TYPES. |