|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 II DR AICD|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the ventak(r) av(tm) ii dr pulse generator models 1821 and 1826, model 2843 application software, version 1. 3 and revisions to the physician's manual, package labeling and patient's manual.