|Trade Name||RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS|
|Classification Name||stimulator, spinal-cord, totally implanted for pain relief|
|Applicant|| MEDTRONIC INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Additional supplier for hybrid components and to qualify two suppliers to perform surrogate inspections.