Premarket Approval (PMA)

Note: 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.

• Device: Exablate Model 4000 System
• Generic Name: MR-guided focused ultrasound system
• Applicant: Insightec; 5 Nahum Heth St.; Tirat Carmel 39120
• PMA Number: P150038
• Supplement Number: S019
• Date Received: 03/08/2022
• Decision Date: 04/06/2022
• Product Code: POH
• Advisory Committee: Neurology
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Change is for a new Extract Trackers Data SW Tool for production in place of the usual manual extract.