NHL — Stimulator, Electrical, Implanted, For Parkinsonian Symptoms Class III
FDA product code NHL covers "Stimulator, Electrical, Implanted, For Parkinsonian Symptoms", a Class III medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.
Classification Details
- Product Code
- NHL
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Unknown
- Implant
- Yes
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.