|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||PRIZM 2|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Generic Name||cardiac resynchronization therapy defibrillator (crt-d) system|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change to the lifted positive df (df+) pad inspection process.