Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
NHL · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
NHL
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
NE
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
Definition
Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic Activa Parkinson's Control Therapy is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinsons disease that are not adequately controlled with medication.