EXABLATE

Mr-guided Focused Ultrasound System

FDA Premarket Approval P150038

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the exablate model 4000 type 1. 0 system (exablate neuro). This device is indicated for use in the unilateral thalamotomy treatment of idiopathic essential tremor patients with medication-refractory tremor. Patients must be at least age 22. The designated area in the brain responsible for the movement disorder symptoms (ventralis intermedius) must be identified and accessible for targeted thermal ablation by the exablate device.

• Device: EXABLATE
• Classification Name: Mr-guided Focused Ultrasound System
• Generic Name: Mr-guided Focused Ultrasound System
• Applicant: InSightec
• Date Received: 2015-10-21
• Decision Date: 2016-07-11
• Notice Date: 2016-07-25
• PMA: P150038
• Supplement: S
• Product Code: POH
• Docket Number: 16M-2183
• Advisory Committee: Neurology
• Expedited Review: No
• Combination Product: No
• Applicant Address: InSightec 5 Nahum Heth Street tirat-hacarmet 39120
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Post-Approval Study: Show Report Schedule and Study Progress
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P150038		Original Filing
S024	2022-10-12	Normal 180 Day Track No User Fee
S023	2022-08-05	Real-time Process
S022
S021	2022-03-10	Real-time Process
S020	2022-03-08	30-day Notice
S019
S018
S017
S016
S015
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

NIH GUDID Devices

Device ID	PMA	Supp
07290019402466	P150038	023
07290019402442	P150038	023