|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||KRONOS LV-T CRT-D|
|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 minor mechanical changes to the ics 3000 programmer including removal of magnets from the pgh wand and replacement of an existing connector as well as associated labeling updates.