|
Device | Exablate Model 4000 System |
Generic Name | MR-guided focused ultrasound system |
Applicant | InSightec 5 NAHUM HETH STREET TIRAT-HACARMET 39120 |
PMA Number | P150038 |
Supplement Number | S019 |
Date Received | 03/08/2022 |
Decision Date | 04/06/2022 |
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 Change is for a new Extract Trackers Data SW Tool for production in place of the usual manual extract. |