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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
Classification Namemr-guided focused ultrasound system
Generic Namemr-guided focused ultrasound system
Applicant
InSightec
5 nahum heth street
tirat-hacarmet 39120
PMA NumberP150038
Supplement NumberS006
Date Received03/07/2018
Decision Date12/16/2018
Product Code
POH[ Registered Establishments with 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 Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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