Urotronic Inc

FDA Filings

This page includes the latest FDA filings for Urotronic Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3015228875
• FEI Number: 3015228875
• Name: UROTRONIC INC
• Owner & Operator: Urotronic Inc
• Contact Address: 2495 Xenium Lane North ; Plymouth MN 55441 US
• Official Correspondent:
  • Brad Andersen
  • x-763-2857480-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2495 Xenium Lane North ; Plymouth, MN 55441 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMA P210020S003 Urotronic, Inc.	Optilume Urethral Drug Coated Balloon	2022-02-03
PMA P210020S002 Urotronic, Inc.	Optilume Urethral Drug Coated Balloon	2022-01-27
PMA P210020S001 Urotronic, Inc.	Optilume Urethral Drug Coated Balloon	2022-01-19
PMA P210020 Urotronic, Inc.	Optilume Urethral Drug Coated Balloon	2021-12-03
PMN K191061 | KOE UROTRONIC INC	Optilume Basic Urological Balloon Dilation Catheter	2020-03-16
PMN K191061 Urotronic Inc	Optilume Basic Urological Balloon Dilation Catheter	2020-01-02

Similar & Related FDA Registered Companies

• Urotronic, Inc.2495 Xenium Laneminneapolis, MN 55441 PMA NumberP210020 Supplement NumberS005 Date Received05/12/2022 Decision Date06/10/2022 Product Code QRH  Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• 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

Related Finance Registrations

NCAGE Code	7TDJ9	UROTRONIC, INC.
CAGE Code	7TDJ9	UROTRONIC, INC.
DUNS	080558603	Urotronic, Inc.
SEC	0001745565	Urotronic, Inc. of DELAWARE