|
Device | Exablate 4000 (“Neuro”) Type 1.0 & 1.1 |
Generic Name | MR-guided focused ultrasound system |
Applicant | InSightec 5 NAHUM HETH STREET TIRAT-HACARMET 39120 |
PMA Number | P150038 |
Supplement Number | S010 |
Date Received | 02/01/2019 |
Decision Date | 11/09/2020 |
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, Protocol Number PD012 – Version 1, amended on April 28, 2020, for the post-approval study (PAS) protocol. |