Urotronic Inc 2495 Xenium Laneminneapolis Mn 55441 Pma Numberp210020 Supplement Numbers004 Date Received02 24 2022 Decision Date05 17 2022 Product Code Qrh Advisory Committee Gastroenterology Urology Supplement Typereal Time Process Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Urotronic Inc 2495 Xenium Laneminneapolis Mn 55441 Pma Numberp210020 Supplement Numbers004 Date Received02 24 2022 Decision Date05 17 2022 Product Code Qrh Advisory Committee Gastroenterology Urology Supplement Typereal Time Process 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 P210020S004 Urotronic, Inc.2495 Xenium Laneminneapolis, MN 55441 PMA NumberP210020 Supplement NumberS004 Date Received02/24/2022 Decision Date05/17/2022 Product Code QRH  Advisory Committee Gastroenterology/Urology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Optilume Urethral Drug Coated Balloon	2022-05-17