|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|| other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for use of ventritex contour(tm) model v-145 and contour(tm) lt model v-135 pulse generators with the medtronic(r) transvene(r) leads and changes in the physician's manuals.