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 Type 1.0 and 1.1 System (“Exablate Neuro”)
• Generic Name: MR-guided focused ultrasound system
• Applicant: Insightec; 5 Nahum Heth St.; Tirat Carmel 39120
• PMA Number: P150038
• Supplement Number: S024
• Date Received: 10/12/2022
• Decision Date: 11/11/2022
• Product Code: POH
• Advisory Committee: Neurology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of the revised protocol for the post-approval study (PAS) protocol.