Insightec5 Nahum Heth Streettirat Hacarmet 39120 Pma Numberp150038 Supplement Numbers020 Date Received03 08 2022 Decision Date03 31 2022 Product Code Poh Advisory Committee Neurology Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Insightec5 Nahum Heth Streettirat Hacarmet 39120 Pma Numberp150038 Supplement Numbers020 Date Received03 08 2022 Decision Date03 31 2022 Product Code Poh Advisory Committee Neurology Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Filings

Device Company	Device	Date
PMA P150038S020 InSightec5 Nahum Heth Streettirat-hacarmet 39120 PMA NumberP150038 Supplement NumberS020 Date Received03/08/2022 Decision Date03/31/2022 Product Code POH  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Exablate Model 4000 System	2022-03-31