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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceOptilume Urethral Drug Coated Balloon Catheter
Generic NameCatheter, Balloon, Urethral, Drug-Coated
ApplicantUrotronic, Inc.
2495 Xenium Ln.
Minneapolis, MN 55441
PMA NumberP210020
Supplement NumberS010
Date Received12/16/2024
Decision Date06/23/2025
Product Code QRH 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for packaging the Optilume Urethral DCB with the Optilume Basic Urological Balloon Dilation Catheter and Atrion Medical QL inflation device into a kit, an additional site to package the proposed kit, and a labeling change to remove the vascular meta-analysis information from the Instruction for Use.
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