|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, IFORIA, LUMAX,|
|Classification Name||defibrillator, implantable, dual-chamber|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - minor|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the minor labeling modifications/ corrections, which includes an update of the indication for use statements (ifu) to include the market approved devices with the same ifu, and other minor corrections to the labeling.