|Trade Name||MEDTRONIC IMPLANTABLE PROGRAMMABLE INFUSION PUMPS|
|Classification Name||pump, infusion, implanted, programmable|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for device refill kit model 8551to reorder the warnings and precautions according to medical importance, to remove information found in the previously approved instructions for use that is not applicable to model 8551, and to align verbiage with the updated model 856x refill kit instructions for use.