|Trade Name||SYNCHROMED II INFUSION PUMP|
|Classification Name||pump, infusion, implanted, programmable|
|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.