|Trade Name||MODEL 3550-39 TITAN ANCHOR|
|Classification Name||stimulator, spinal-cord, totally implanted for pain relief|
|Applicant|| MEDTRONIC INC.|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for: 1) removal of the xylene mixing step; 2) addition of a secondary silicone adhesive step and cure; and 3) modification of the incoming receiving inspection process with the addition of a process monitor.