|Trade Name||ISOMED IMPLANTABLE INFUSION SYSTEMS|
|Classification Name||pump, infusion, implanted, programmable|
|Applicant|| MEDTRONIC INC.|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to: 1) update the labeling for these devices to specifically reference infumorph (preservative-free morphine sulfate sterile solution) in the treatment of chronic intractable pain; and 2) to add language to identify the maximum concentration for infumorph that can be delivered through the isomed implantable infusion systems.