Flowonix Medical Inc 500 I N T Drivesuite 200mt Olive Nj 07828 Pma Numberp080012 Supplement Numbers072 Date Received03 30 2022 Decision Date04 28 2022 Product Code Lkk Advisory Committee General Hospital Supplement Typespecial Immediate Track Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Flowonix Medical Inc 500 I N T Drivesuite 200mt Olive Nj 07828 Pma Numberp080012 Supplement Numbers072 Date Received03 30 2022 Decision Date04 28 2022 Product Code Lkk Advisory Committee General Hospital Supplement Typespecial Immediate Track Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename 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 P080012S072 FLOWONIX MEDICAL, INC.500 International Drivesuite 200mt.olive, NJ 07828 PMA NumberP080012 Supplement NumberS072 Date Received03/30/2022 Decision Date04/28/2022 Product Code LKK  Advisory Committee General Hospital Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	Prometra Programmable Infusion Pump System	2022-04-28