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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceExAblate
Generic NameMR-guided focused ultrasound system
ApplicantInsightec
5 Nahum Heth St.
Tirat Carmel, Park High-Tech North 39120
PMA NumberP150038
Supplement NumberS006
Date Received03/07/2018
Decision Date12/16/2018
Product Code POH 
Docket Number 19M-4780
Notice Date 01/25/2019
Advisory Committee Neurology
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Exablate Model 4000 (Neuro). The device is intended in the unilateral Thalamotomy (ventralis intermedius) treatment of Tremor-dominant Parkinson’s Disease with medication-refractory tremor. Patients must be at least age 30.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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