|
Device | EXABLATE |
Generic Name | MR-guided focused ultrasound system |
Applicant | InSightec 5 NAHUM HETH STREET TIRAT-HACARMET 39120 |
PMA Number | P150038 |
Supplement Number | S002 |
Date Received | 01/17/2017 |
Decision Date | 04/17/2017 |
Product Code |
POH |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a new Magnetic Resonance (MR) Head Coil for compatibility and use with the 1.5 Tesla (T) MR scanner environment when used with the ExAblate Model 4000 Type 1.0 System. |