|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(R) PRX (TM) II AICD SYSTEM|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Generic Name||software application|
|Supplement Type||normal 180 day track|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the use of model 2872 software application, rev. 4. 1 and model 2909 multiple application utility (mau) with the ventak prx ii/iii pulse generator and model 2950 prm.