|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 VR/DR/HF (-T) ICD'S & CRT-D'S|
|Classification Name||defibrillator, implantable, dual-chamber|
|Supplement Type||real-time process|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes to: 1) geometrical dimensions of the flange of the feedthrough; and 2) insulating glass type 8455 has been replaced by glass type 8250.