|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||IFORIA/ILESTO 5/7 DR-T/VR-T/VR-T DX/HF-T; KRONOS LV-T, VARIOUS LUMAX MODELS CRT-D'S|
|Classification Name||defibrillator, implantable, dual-chamber|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the removal of the scan location restrictions for the promri pacemaker system as well as updates to the ics 3000/ renamic programmer software (1403. U) for the devices.