|
Device | Exablate 4000 (Exablate Neuro) |
Generic Name | MR-guided focused ultrasound system |
Applicant | InSightec 5 NAHUM HETH STREET TIRAT-HACARMET 39120 |
PMA Number | P150038 |
Supplement Number | S021 |
Date Received | 03/10/2022 |
Decision Date | 06/07/2022 |
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 replacement of the Control Personal Computer (PC) and Workstation PC to address end-of-life and software-related defects. |