|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||FLEX TIP INTRASPINAL KIT, CATALOG AP-07008|
|Classification Name||pump, infusion, implanted, programmable|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the flex tip plus intraspinal catheter kit, catalog ap-07008. This catheter kit will be used with the model 3000 implantable pump with bolus safety valve for intraspinal delivery of preservative free morphine to patients with chronic intractable pain.