|
Device | EXABLATE |
Generic Name | MR-guided focused ultrasound system |
Applicant | InSightec 5 NAHUM HETH STREET TIRAT-HACARMET 39120 |
PMA Number | P150038 |
Date Received | 10/21/2015 |
Decision Date | 07/11/2016 |
Product Code |
POH |
Docket Number | 16M-2183 |
Notice Date | 07/25/2016 |
Advisory Committee |
Neurology |
Clinical Trials | NCT01827904
|
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the ExAblate Model 4000 Type 1.0 System (ExAblate Neuro). This device is indicated for use in the unilateral Thalamotomy treatment of idiopathic Essential Tremor patients with medication-refractory tremor. Patients must be at least age 22. The designated area in the brain responsible for the movement disorder symptoms (ventralis intermedius) must be identified and accessible for targeted thermal ablation by the ExAblate device. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S018 S019 S020 S021 S022 S023 S024 S025 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 |