|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||MEDTRONIC ATTAIN OTW LV LEAD MODEL 4193|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| labeling change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to add an updated version of the post-approval study summary for the attain otw lv lead model 4193 to the device labeling.