|Trade Name||SPINAL CORD STIMULATION FAMILY OF NEUROSTIMULATION LEADS|
|Classification Name||stimulator, spinal-cord, totally implanted for pain relief|
|Generic Name||stimulator, spinal-cord, totally implanted for pain relief|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| location change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for an alternate manufacturing site located at benchmark electronics, inc. , winona, minnesota for the manufacture of the medtronic model 3625 test stimulator.