FDA product code NHL: Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

NHL is the FDA product code for stimulator, electrical, implanted, for parkinsonian symptoms. It is a Class III device, reviewed by the Neurology panel. Devices under NHL reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 4 recalls for NHL devices, 3 initiated in the last five years.

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.

Classification

Recalls for NHL devices

4 product recalls in 4 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-07-08.

Frequently asked questions

What is FDA product code NHL?

NHL is the FDA product code for stimulator, electrical, implanted, for parkinsonian symptoms. It is a Class III device, reviewed by the Neurology panel.

What device class is NHL?

Class III. Typical premarket route: PMA.

Have NHL devices been recalled?

Yes: 4 product recalls across 4 recall events; the most recent began 2025-07-08.

Next steps

• Run an FDA pathway report with predicate devices for product code NHL
• Run a recall and safety report across every NHL manufacturer
• Watch product code NHL for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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