|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||IMPELLA 2.5 SYSTEM|
|Classification Name||temporary non-roller type cardiac support blood pump|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for an upgrade of the automated impella controller (aic) software to version 5. 0.