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.
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.
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.
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.
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