|Trade Name||MEDTRONIC MODEL 8711 TWO PIECE INTRATHECAL CATHETER|
|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 a design change to the model 8703w intraspinal catheter. The resulting catheter incorporates the same materials and basic design as model 8703w except for a closed distal tip with six side holes instead of a single open tip. The device, as modified, will be marketed under the trade name medtronic(r) model 8711 two piece intrathecal catheter and is indicated for the containment and delivery of parenteral drugs to the intrathecal space of the spinal cord.