|Trade Name||ARROW INTERNATIONAL MODEL 3000/3000-16/3000-50 IMPLANTABLE|
|Classification Name||pump, infusion, implanted, programmable|
|Generic Name||pump, infusion, implanted, programmable|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the following modifications to the device: 1)replacement of the standard 50 ml syring with a calibrated syringe in the refill kit and related labeling; 2) the incorporation of a special bolus winged infusion set; 3) increase the volume of water placed into the pump reservoir prior to sterilization; 4) revise the labeling to refer the user to the instruction for use of the device.