|
Device | Exablate Model 4000 Type 1.0 and 1.1 Systems |
Generic Name | MR-guided focused ultrasound system |
Applicant | InSightec 5 NAHUM HETH STREET TIRAT-HACARMET 39120 |
PMA Number | P150038 |
Supplement Number | S018 |
Date Received | 12/14/2021 |
Decision Date | 07/29/2022 |
Product Code |
POH |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the revised protocol for the post-approval study (PAS) protocol. |