|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||COROX OTW 85 UP STEROID, LUMAX 300 DR-T, LUMAX 340 DR-T,LUMAX 300 VR-T, LUMAX 340 VR-T, LUMAX 500 DR-T,LUMAX 540 DR-T, L|
|Classification Name||defibrillator, implantable, dual-chamber|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Reclassifying the environmental conditions from class d to iso 8 cleanrooms.