ExAblate Neuro Thalamotomy

Mr-guided Focused Ultrasound System

FDA Premarket Approval P150038 S004

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

Approval of the revised protocol for the post-approval study (pas) protocol.

• Device: ExAblate Neuro Thalamotomy
• Classification Name: Mr-guided Focused Ultrasound System
• Generic Name: Mr-guided Focused Ultrasound System
• Applicant: InSightec
• Date Received: 2017-08-16
• Decision Date: 2017-10-13
• PMA: P150038
• Supplement: S004
• Product Code: POH
• Advisory Committee: Neurology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - Ode/oir
• Expedited Review: No
• Combination Product: No
• Applicant Address: InSightec 5 Nahum Heth Street tirat-hacarmet 39120

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