|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||MEDTRONIC NEUROSTIMULATION SYSTEM (ITREL 3, RESTORE, SYNERGY, SYNERGY VERSITREL SYNERGY PLUS+, AND SYNERGY COMPACT PLUS+|
|Classification Name||stimulator, spinal-cord, totally implanted for pain relief|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for revised text to the caution in the "placing a percutaneous lead" section of the instructions for use section of the following manuals: model 3898 pisces-octad lead kit implant manual, model 3487 a pisces quad, model 3887 pisces quad compact, and model 3888 pisces quad plus lead kits implant manual, and model 3890 pisces z quad, model 3891 pisces z quad compact, and model 3892 pisces z quad plus lead kits implant manual.