Brio Neurostimulation System

FDA premarket approval P140009 · Stimulator, electrical, implanted, for parkinsonian tremor

PMA numberP140009

Approval

Applicant
Abbott Medical
Received
May 5, 2014
Decision date
June 12, 2015 (APPR)
Supplements
134, latest September 11, 2026
Product code
MHY – Stimulator, Electrical, Implanted, For Parkinsonian Tremor

Official FDA PMA record

Approval order statement

APPROVAL FOR THE BRIO NEUROSTIMULATION SYSTEM. THIS DEVICE IS INDICATED FOR THE FOLLOWING CONDITIONS:1) BILATERAL STIMULATION OF THE SUBTHALAMIC NUCLEUS (STN) AS AN ADJUNCTIVE THERAPY TO REDUCE SOME OF THE SYMPTOMS OF ADVANCED LEVODOPA-RESPONSIVE PARKINSONS DISEASE THAT ARE NOT ADEQUATELY CONTROLLED BY MEDICATIONS; AND 2) UNILATERAL OR BILATERAL STIMULATION OF THE VENTRAL INTERMEDIATE NUCLEUS (VIM) OF THE THALAMUS FOR THE SUPPRESSION OF DISABLING UPPER EXTREMITY TREMOR IN ADULT ESSENTIALTREMOR PATIENTS WHOSE TREMOR IS NOT ADEQUATELY CONTROLLED BY MEDICATIONS AND WHERE THE TREMOR CONSTITUTES A SIGNIFICANT FUNCTIONAL DISABILITY.