|
Device | EXABLATE NEURO THALAMOTOMY |
Generic Name | MR-guided focused ultrasound system |
Applicant | InSightec 5 NAHUM HETH STREET TIRAT-HACARMET 39120 |
PMA Number | P150038 |
Supplement Number | S001 |
Date Received | 08/03/2016 |
Decision Date | 09/29/2016 |
Product Code |
POH |
Advisory Committee |
Neurology |
Clinical Trials | NCT02289560
|
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 protocol for the ODE Lead PMA Post-Approval Study protocol. |