|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||LUMAX FAMILIES OF ICD'S & CRT-D'S|
|Classification Name||defibrillator, implantable, dual-chamber|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Two new welding stations, copying existing processes from one workstation to another and minor process parameter changes.