510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NHLClass III

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

Unknown
FDA source (opens on fda.gov)

NHL is the FDA product code for Stimulator, Electrical, Implanted, For Parkinsonian Symptoms, a class III device type. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and 4 recalls.

Classification record

Product code
NHL
Device name
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
FDA 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.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 27 companies shown, in name order