|Trade Name||MEDTRONIC SYNCHROMED IMPLANTABLE INFUSION PUMP|
|Classification Name||pump, infusion, implanted, programmable|
|Generic Name||implantable infusion pumps|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for addition of an alternate catheter port for use with the synchromed pump, model 8508 cap; addition of an application specific integrated circuit (asic) buffer chip to the pumps hybrid to improve battery longevity; addition of another suture loop to the shield; change in the device name from synchromed(tm) to synchromed el(tm); change in model numbers (new model numbers represent new synchromed el pumps); and change to labeling.