|
Device | BRIO NEUROSTIMULATION SYSTEM |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | Abbott Medical 6901 Prestion Road Plano, TX 75024 |
PMA Number | P140009 |
Date Received | 05/05/2014 |
Decision Date | 06/12/2015 |
Product Codes |
MHY NHL PJS |
Docket Number | 15M-2497 |
Notice Date | 07/10/2015 |
Advisory Committee |
Neurology |
Clinical Trials | NCT00552474
|
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
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. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 S019 S020 S021 S022 S023 S024 S025 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 S051 S052 S053 S054 S055 S056 S057 S058 S059 S060 S061 S062 S063 S064 S065 S066 S067 S068 S069 S070 S071 S072 S073 S074 S075 S076 S077 S078 S079 S080 S081 S082 S083 S084 S085 S086 S087 S088 S089 S090 S091 S092 S094 S095 S096 S097 S098 S099 S100 S101 S102 S104 S105 |