ExAblate

Mr-guided Focused Ultrasound System

FDA Premarket Approval P150038 S006

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 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.

DeviceExAblate
Classification NameMr-guided Focused Ultrasound System
Generic NameMr-guided Focused Ultrasound System
ApplicantInSightec
Date Received2018-03-07
Decision Date2018-12-16
Notice Date2019-01-25
PMAP150038
SupplementS006
Product CodePOH
Docket Number19M-4780
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
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P150038Original 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 IDPMASupp
07290019402466 P150038 023
07290019402442 P150038 023

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.