Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)

FDA Premarket Approval P150038 S014

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.

Pre-market Approval Supplement Details

The exablate neuro is indicated for use in the unilateral pallidotomy of patients with advanced, idiopathic parkinson’s disease with medication-refractory moderate to severe motor complications as an adjunct to parkinson’s disease medication treatment. Patients must be at least age 30. The designated area in the brain responsible for the movement disorder symptoms [globus pallidus (gpi)] must be identified and accessible for targeted thermal ablation by the exablate device.

DeviceExablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)
Generic NameMr-guided Focused Ultrasound System
ApplicantInSightec
Date Received2021-03-31
Decision Date2021-10-29
PMAP150038
SupplementS014
Product CodePOH 
Advisory CommitteeNeurology
Supplement TypePanel Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address InSightec 5 Nahum Heth Street tirat-hacarmet 39120

Supplemental Filings

Supplement NumberDateSupplement Type
P150038Original Filing
S014 2021-03-31 Panel Track
S013 2020-10-23 Normal 180 Day Track
S012 2019-08-08 Normal 180 Day Track
S011 2019-03-26 30-day Notice
S010
S009
S008 2018-07-23 Normal 180 Day Track
S007 2018-04-23 30-day Notice
S006 2018-03-07 Panel Track
S005 2018-02-20 Normal 180 Day Track
S004 2017-08-16 Normal 180 Day Track No User Fee
S003 2017-03-28 Normal 180 Day Track
S002 2017-01-17 Normal 180 Day Track
S001 2016-08-03 Normal 180 Day Track No User Fee

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