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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 | S023 |
Date Received | 08/05/2022 |
Decision Date | 11/02/2022 |
Product Code |
POH |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of another sterile disposable head ring screws (DHRS) option, manufactured by INSIGHTEC and marketed under a name PFK (Patient Fixation Kit), as an accessory to Exablate Neuro system. |