Recently Approved Devices

AngelMed Guardian System - P150009 The AngelMed Guardian System is a implantable cardiac monitor intended to detect and alert patients of a potential heart attack consisting of three components: the Implantable Medical Device (IMD), the External Device (EXD), and the programmer collecting and storing information about the patient's heart electrical activity. Continue reading. LIPOSORBER® LA-15 System - H170002 The LIPOSORBER LA-15 System is a blood processing system that collects blood from the patient's body and removes certain substances such as low density lipoprotein cholesterol (LDL-C, or "bad cholesterol") and other harmful substances from the patient's blood. The system also helps slow the progression of an aggressive kidney disease called Focal segmental glomerulosclerosis (FSGS). The system is comprised of a tubing set, two blood filters, two blood storage columns, and a computer that controls the entire system. Continue reading. ZOLL® AED Plus® and Fully Automatic AED Plus® - P160015 The ZOLL® AED Plus® Automated External Defibrillator (AED) and Fully Automatic AED Plus® are portable, battery operated, public access defibrillators designed to treat people experiencing sudden cardiac arrest (SCA), a medical condition in which the heart suddenly and unexpectedly stops beating. Continue reading. Medtronic DBS System for Epilepsy - P960009/S219 The Medtronic Deep Brain Stimulation (DBS) System for Epilepsy is a device that delivers controlled electrical pulses to a location inside the brain which is involved in seizures. The system consists of a pulse generator (IPG) implanted under the skin of the upper chest, and two leads implanted in the brain. The Medtronic DBS System for Epilepsy helps reduce the frequency of seizures in epilepsy patients who have frequent, disabling, partial-onset seizures and have not responded well to antiepileptic medications. Continue reading.