|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)|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for replacing the current connector top material for aicd models:1705, prx ii model 1715, and prx iii models 1720/1725, pellethane 2363-75d polyurethane, with tecothane tt1075d-m polyurethane.