|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||VENTAK MINI AICD SYSTEM|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the ventak mini aicd system, which includes:model numbers 1645, 1740, 1741, 1745, and 1746 pulse generators; model 2840 software application; model 2909 multiple application utility (mau); and model 6996 df-1 plug.