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

FDA Premarket Approval P150038 S023

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

DeviceExablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)
Generic NameMr-guided Focused Ultrasound System
ApplicantInSightec5 Nahum Heth Streettirat-hacarmet 39120 PMA NumberP150038 Supplement NumberS023 Date Received08/05/2022 Decision Date11/02/2022 Product Code POH  Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Date Received2022-08-05
Decision Date2022-11-02
PMAP150038
SupplementS023
Product CodePOH 
Advisory CommitteeNeurology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductNo
Applicant AddressInSightec
5 Nahum Heth Street
tirat-hacarmet 39120 PMA NumberP150038 Supplement NumberS023 Date Received08/05/2022 Decision Date11/02/2022 Product Code POH  Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement  
the Addition Of Another Sterile Disposable Head Ring Screws (DHRS) Option, Manufactured By INSIGHTEC And Marketed Under A Name PFK (Patient Fixation Kit), As An Accessory To Exablate Neuro System

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

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