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

FDA Premarket Approval P150038 S024

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 NumberS024 Date Received10/12/2022 Decision Date11/11/2022 Product Code POH  Advisory Committee Neurology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
Date Received2022-10-12
Decision Date2022-11-11
PMAP150038
SupplementS024
Product CodePOH 
Advisory CommitteeNeurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination ProductNo
Applicant AddressInSightec
5 Nahum Heth Street
tirat-hacarmet 39120 PMA NumberP150038 Supplement NumberS024 Date Received10/12/2022 Decision Date11/11/2022 Product Code POH  Advisory Committee Neurology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement  
approval Of The Revised Protocol For The Post-approval Study (PAS) Referenced Above. The PAS Protocol Has Been Submitted To Comply With The Conditions Of Approval Outlined In Our Approval Order For P150038/S006

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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