|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 DEFIBRILLATOR 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 a new version of programmer software for the ventritex(r) programmer pr-1500. The device, as modified, will be marketed under the trade name prs v4. 2h and is indicated for use with programmer pr-1500 and cadence pulse generator models v-105, v-115 and contour pulse generator models v-135, v-145.