|
Device | ExAblate |
Generic Name | MR-guided focused ultrasound system |
Applicant | InSightec 5 NAHUM HETH STREET TIRAT-HACARMET 39120 |
PMA Number | P150038 |
Supplement Number | S006 |
Date Received | 03/07/2018 |
Decision Date | 12/16/2018 |
Product Code |
POH |
Docket Number | 19M-4780 |
Notice Date | 01/25/2019 |
Advisory Committee |
Neurology |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the Exablate Model 4000 (Neuro). The device is intended in the unilateral Thalamotomy (ventralis intermedius) treatment of Tremor-dominant Parkinson’s Disease with medication-refractory tremor. Patients must be at least age 30. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |