|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||RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS|
|Supplement Type||normal 180 day track|
|Supplement Reason|| other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to consider the information provided in this supplement as an alternative response to the conditions of approval set forth in the fda letter dated november 7, 1995. The condition required that remaining minor software anomalies be corrected.