Urotronic Inc 2495 Xenium Laneminneapolis Mn 55441 Pma Numberp210020 Supplement Numbers006 Date Received08 30 2022 Decision Date09 29 2022 Product Code Qrh Advisory Committee Gastroenterology Urology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Urotronic Inc 2495 Xenium Laneminneapolis Mn 55441 Pma Numberp210020 Supplement Numbers006 Date Received08 30 2022 Decision Date09 29 2022 Product Code Qrh Advisory Committee Gastroenterology Urology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol 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 P210020S006 Urotronic, Inc.2495 Xenium Laneminneapolis, MN 55441 PMA NumberP210020 Supplement NumberS006 Date Received08/30/2022 Decision Date09/29/2022 Product Code QRH  Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No	Optilume Urethral Drug Coated Balloon	2022-09-29