|Trade Name||LIFEVEST (WCD 3000S) WEARABLE DEFIBRILLATOR|
|Classification Name||wearable automated external defibrillator|
|Generic Name||wearable cardioverter defibrillator|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - minor|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modifications to the lifevest wcd 3000 device to better facilitate short-term use. The device, as modified, will be marketed under the trade name lifevest wcd 3000s and is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator. The lifevest wcd 3000s system is intended for short-term use in a medically supervised environment. The device is not intended to be worn home.