|Trade Name||ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS|
|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|
|Supplement Reason|| location change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for an alternate manufacturing facility for the model 7495 and model 7495lz extensions. The ficility is located at medtronic neurological puerto rico operations, villalba, puerto rico.