|Trade Name||SOLETRA/KINETRA/EXTERNAL/ACTIVA FAMILY OF NEUROSTIMULATORS|
|Classification Name||stimulator, electrical, implanted, for parkinsonian tremor|
|Applicant|| MEDTRONIC INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Implementation of updated hardware and software for the barcode/optical character recognition labeler system as well as a process change pertaining to the upgraded labeler system.