|Trade Name||NEUROSTIMULATION SYSTEMS FOR SPINAL CORD STIMULATION (SCS)|
|Classification Name||stimulator, spinal-cord, totally implanted for pain relief|
|Generic Name||stimulator, spinal-cord, totally implanted for pain relief|
|Supplement Type||special (immediate track)|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to provide corrections to the labeling related to the cycling feature (alternating between therapy off and on) in some neurostimulation devices used for spinal cord stimulation and deep brain stimulation.