This page includes the latest FDA filings for Insightec5 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. 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 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 | Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”) | 2022-11-11 |