|Trade Name||SYNCHROMED AND SYNCHROMED II IMPLANTABLE INFUSION PUMPS|
|Classification Name||pump, infusion, implanted, programmable|
|Generic Name||implantable infusion pumps|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for: the addition of time labels and a daily dose filed to the programming screens; the addition of recently approved catheter models, model 8731 and model 8749, to the drop-down list; changes to the screen used to enter the demo mode, and the resulting updates to the programming guides.