|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.|
|Classification Name||defibrillator, implantable, dual-chamber|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
A change in sterilization load configuration; 2) change in sterilization pre-conditioning; 3) sterilization injection parameter changes; and 4) change to the process challenge device.