Theragen Inc 11220 Assett Loopsuite 101manassas Va 20109 Pma Numberp190030 Supplement Numbers001 Date Received04 08 2022 Decision Date06 17 2022 Product Code Lof Advisory Committee Orthopedic Supplement Typereal Time Process Supplement Reason Change Design Components Specifications Material Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Theragen Inc 11220 Assett Loopsuite 101manassas Va 20109 Pma Numberp190030 Supplement Numbers001 Date Received04 08 2022 Decision Date06 17 2022 Product Code Lof Advisory Committee Orthopedic 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.

FDA Filings

Device Company	Device	Date
PMA P190030S001 Theragen, Inc.11220 Assett Loopsuite 101manassas, VA 20109 PMA NumberP190030 Supplement NumberS001 Date Received04/08/2022 Decision Date06/17/2022 Product Code LOF  Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No	ActaStim-S Spine Fusion Stimulator	2022-06-17