|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||LLESTO 7 VR-T, IFORIA 7 VR-T, LLESTO 5 VR-T, IFORIA 5 VR-T, LUMAX 740 VR-T, LLESTO 7 DR-T, IFORIA 7 DR-T, LLESTO 5 DR-T|
|Classification Name||defibrillator, implantable, dual-chamber|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change to the labeling software which is used to print labels for the devices.