|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|| Special Supplement|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the implementation of additional quality control measurements for fluid tightness of the impella purge cassette.