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Device | Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”) |
Generic Name | MR-guided focused ultrasound system |
Applicant | InSightec 5 NAHUM HETH STREET TIRAT-HACARMET 39120 |
PMA Number | P150038 |
Supplement Number | S014 |
Date Received | 03/31/2021 |
Decision Date | 10/29/2021 |
Product Code |
POH |
Docket Number | 21M-1182 |
Notice Date | 11/03/2021 |
Advisory Committee |
Neurology |
Clinical Trials | NCT03319485
|
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 Neuro. The device is indicated for use in the unilateral pallidotomy of patients with advanced, idiopathic Parkinsons disease with medication-refractory moderate to severe motor complications as an adjunct to Parkinsons disease medication treatment. Patients must be at least age 30. The designated area in the brain responsible for the movement disorder symptoms [globus pallidus (GPi)] must be identified and accessible for targeted thermal ablation by the Exablate device. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Post-Approval Study | Show Report Schedule and Study Progress |