|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.|
|Classification Name||pump, infusion, implanted, programmable|
|Generic Name||pump, infusion, implanted, programmable|
|Supplement Type||special (immediate track)|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for updated warning and precautions and procedures related to subcutaneous overdose.