|
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 | S035 |
Date Received | 01/29/2024 |
Decision Date | 02/26/2024 |
Product Code |
POH |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement a change to the in-process specification of the individual tile level impedance testing to accept a different range of impedances |