|
Device | Exablate 2100/2100V1 System |
Generic Name | Ablation system, high intensity focused ultrasound (HIFU), MR-guided |
Applicant | InSightec 5 NAHUM HETH STREET TIRAT-CARMEL 39120 |
PMA Number | P110039 |
Supplement Number | S010 |
Date Received | 04/26/2018 |
Decision Date | 08/16/2018 |
Product Code |
NRZ |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for modification to the connector port between the MRI scanner and the ExAblate 2100/2100VI System. |