|Trade Name||MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Generic Name||dual-chamber adaptive-rate pacemaker|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes to the model 2890 software application from version 1. 20 to version 2. 12 which consist primarily of usability changes (screen changes, usability features), corrections of anomalies, and the addition of a high rate single chamber temporary pacing mode (up to 380 ppm) to the discovery(tm)/meridian(tm) pacemakers which provides consistency with the vigor pacemakers.