|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||CADENCE(R) TIERED THERAPY DEFIBRILLATION 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 programmer software version 4. 0 with the cadence models v-100, v-110 or v-112 implantable defibrillator.