|Trade Name||ITREL SPINAL CORD STIMULATION SYSTEM|
|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|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the use of an alternative packaging material, uncoated petg (polyethylene terephthalate, glycol modifed) for the manufacture of the inner and outer packaging trays. The device, as modified, will be marketed under the trade name itrel and is indicated for spinal cord stimulation.