|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||VITATRON DIVA PLATFORM|
|Classification Name||implantable pacemaker pulse-generator|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - shelf-life|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for an extension of the shelf life date to 18 months from 12 months and related labeling changes.