|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||TUPOS LV/ATX, KRONOS LV-T, LUMAX 300/340 FAMILY OF ICDS AND CRT-DS|
|Classification Name||defibrillator, implantable, dual-chamber|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes to the visual inspection criteria for glass feedthroughs used in batteries.