DevicePMAs@therightstef:P010030_S056 JSONTXT 13 Projects

Approval for the lifevest wearable cardioverter defibrillator, models 3000, 3100, and 4000. the lifevest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator. the lifevest system isindicated for patients under 18 years of age who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator. Patients must have a chest circumference of 26 inches (66 centimeters) or greater and a weight of 18.75 kilograms (41.3 pounds) or greater.