|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 ICDS/CRT-DS|
|Classification Name||defibrillator, implantable, dual-chamber|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Removal of the 72 hour storage condition during the header attachment process.