This page includes the latest FDA filings for Insightec5 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. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Device Company | Device | Date |
|---|---|---|
| InSightec5 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 | Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”) | 2022-11-02 |