|
Device | ExAblate |
Generic Name | MR-guided focused ultrasound system |
Applicant | InSightec 5 NAHUM HETH STREET TIRAT-HACARMET 39120 |
PMA Number | P150038 |
Supplement Number | S003 |
Date Received | 03/28/2017 |
Decision Date | 06/26/2017 |
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 software maintenance upgrade from Software Version 6.6 to Version 7.0 for the unilateral Thalamotomy treatment of idiopathic Essential Tremor (ET) patients with medication –refractory tremor. |