|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||ACUITY STEERABLE|
|Classification Name||drug eluting permanent left ventricular (lv) pacemaker electrode|
|Supplement Type||real-time process|
|Supplement Reason|| process change: packaging|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a new outer sales box and closure labels for the leads.