|Classification Name||wearable automated external defibrillator|
|Generic Name||wearable automated external defibrillator|
|Applicant||ZOLL MANUFACTURING CORPORATION|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|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.