|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||INTRATHECAL CATHETER MODELS 8709, 8711, 8709SC, 8731SC, AND REVISION KIT 8598A|
|Classification 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: 1) a new catheter tip push-out force specification; 2) a modified manufacturing monitoring process to assure conformance to new catheter tip push-out force specification; 3) a change to the catheter tip material for catheter model 8731sc and revision kit model 8598a; and 4) labeling revisions.