|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.|
|Classification Name||wearable automated external defibrillator|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - trade name|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a new trade name for the wcd device. The device, as modified, will be marketed under the trade name lifevest and is indicated for adult patients who are at risk for sudden cardiac arrest and either are not candidates for or refuse an implantable defibrillator.