|Trade Name||ITREL3, SYNERGY AND SYNERGY VERSITREL NEUROSTIMULATORS|
|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|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the model 3890 pisces z quad lead, model 3891 pisces z quad compact lead, model 3892 pisces z quad plus lead and model 3550-22 and 3550-23 lead revision kits. The devices are indicated as an aid in the management of chronic, intractable pain of the trunk or limbs.