|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||VENTAK AV III DR PULSE GENERATOR AND VENTAK AV DR SOFTWARE APPLICATION|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the ventak(r) av iii dr aicd(tm) system with model 2843 software, version 2. 6, the use of version 2. 6 with the ventak(r) av ii dr system and modifications to the physician's manual and the dr system and modifications tot he physicians's manual and the patient's manual.