|Trade Name||MEDTRONIC RESTORE FAMILY IMPLANTABLE NEUROSTIMULATORS|
|Classification Name||stimulator, spinal-cord, totally implanted for pain relief|
|Generic Name||stimulator, spinal-cord, totally implanted for pain relief|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a minor design change to the feedthrough and for the use of acetone for the removal and replacement of the connector block in the manufacturing rework process.