|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||DEMA, DIVA AND AFM PULSE GENERATORS|
|Classification Name||implantable pacemaker pulse-generator|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the software version pro vit vsa02 v6. 1 dema, diva, and selection of afm pulse generators.