Arj Medical Inc 209 State Street Eoldsmar Fl 34677 Pma Numberp170022 Supplement Numbers001 Date Received05 04 2022 Decision Date11 30 2022 Product Code Oza Advisory Committee Microbiology 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 Arj Medical Inc 209 State Street Eoldsmar Fl 34677 Pma Numberp170022 Supplement Numbers001 Date Received05 04 2022 Decision Date11 30 2022 Product Code Oza Advisory Committee Microbiology 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 P170022S001 ARJ Medical Inc.209 State Street Eoldsmar, FL 34677 PMA NumberP170022 Supplement NumberS001 Date Received05/04/2022 Decision Date11/30/2022 Product Code OZA  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No	PyloPlus Urea Breath Test Pro Analyzer, PyloPlus Urea Breath Test Lab Analyzer	2022-11-30