DevicePMAs@therightstef:P010030_S063 JSONTXT

Approval for v07.5 monitor software which includes nine software changes to the lifevest wearabledefibrillator 4000 monitor, the device, as modified, will be marketed under the trade name lifevest wearable defibrillator 4000 and is indicated for adult patients who are at risk forsudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.