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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 NumberS002
Date Received05/21/2024
Decision Date08/15/2024
Product Code QXB 
Advisory Committee Gastroenterology/Urology
Clinical TrialsNCT04131907
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a change in supplier for two kit components (i.e., the Tuohy-Borst adapter and stopcock), a change in kit packaging of the components (i.e., addition of the Tuohy-Borst adapter and Stopcock to the Pre-Dilation Catheter Tyvek Pouch), and a change in labeling to remove the vascular meta-analysis information from the Instructions for Use
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