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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 NumberS004
Date Received11/25/2025
Decision Date12/12/2025
Product Code QXB 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
a change of an additional pre-dilation catheter supplier manufacturing site
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