|Trade Name||MEDTRONIC SPINAL CORD STIMULATION SYSTEMS|
|Classification Name||stimulator, spinal-cord, totally implanted for pain relief|
|Applicant|| MEDTRONIC INC.|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes being effected to the labeling of medtronic spinal cord stimulation systems. Specifically, a possible adverse event delayed spinal cord compression due to epidural mass formation is being added to the labeling.