|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 CRT DEVICE & CARDIOMESSENGER II|
|Classification Name||defibrillator, implantable, dual-chamber|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modifications to the cardiomessenger and cardiomessenger ii used with the referenced devices. The devices, as modified, will be marketed under the trade names: cardiomessenger tline and cardiomessenger ii llt and are indicated for transmitting diagnostic patient data from the device to the physician.