|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||LUMAX 500/540 ICDS THORACIC IMPEDANCE|
|Classification Name||defibrillator, implantable, dual-chamber|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of the thoracic impedance (ti) measurement feature to the currently approved lumax 500/540 implantable cardioverter defibrillators and cardiac resynchronization defibrillator devices.