|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 300 DR-T/LUMAX 340 DR-T,LUMAX 300 VR-T/LUMAX 340 VR-T,LUMAX 500 DR-T/LUMAX 540 DR-T,LUMAX 500 VR-T/LUMAX 540 VR-T,|
|Classification Name||defibrillator, implantable, dual-chamber|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the updated version 3. 22. 0 of home monitoring service center including the features: 1) implementation of remote scheduling; and 2) automatic export of ehr data.