|Trade Name||BIOTRONIK GEMNOS 04, 04A, AND TC 04|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Generic Name||implantable pulse generator, pacemaker (non-crt)|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the change in the burn-in processing of the wilson greatbatch batteries which are used in your listed pacemakers. This process change is a reduction of the battery burn-in time from 35 days to 4 days.