|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 - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for cadet high-voltage can icd models v-105ac and v-115ac, cadet test can model ac-cdt-tcn, cadet test cable model ac-cdt-tcb, contour high-voltage can icd models v-135ac and v-145ac, contour test can model ac-tcn and contour test cable model ac-tcb.