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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™ BPH Catheter System
Generic NameDrug coated prostatic dilation catheter for benign prostatic hyperplasia
ApplicantUrotronic, Inc.
2495 Xenium Ln.
Minneapolis, MN 55449
PMA NumberP220029
Supplement NumberS003
Date Received11/17/2025
Decision Date12/15/2025
Product Code QXB 
Advisory Committee Gastroenterology/Urology
Clinical TrialsNCT04131907
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the revised protocol for the post-approval study (PAS)
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