|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||VARIOUS MODELS OF LUMAX ICD/CRT-D FAMILIES; COROX OTW UP STEROID LEAD|
|Classification Name||defibrillator, implantable, dual-chamber|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| location change: sterilizer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a manufacturing site located at sterigenics germany gmbh, wiesbaden, germany as an alternate sterilization facility.