|
Device | Exablate Model 4000 Type 1.0 & Type 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 | S033 |
Date Received | 11/22/2023 |
Decision Date | 01/21/2024 |
Product Code |
POH |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement approval for a manufacturing site located at R.H. Electronics Ltd., 5 Hatzoref St. Har-Yona Industrial Area, Nof Hagalil, Nazereth Illit, 17000, Israel, for assembly activities of the Exablate Neuro treatment kits |