• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device stimulator, electrical, implanted, for parkinsonian symptoms
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.
Review Panel Neurology
Product CodeNHL
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurostimulation Devices Branch (NSDB)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
-
-