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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceOptilume™ BPH Catheter System
Generic NameDrug coated prostatic dilation catheter for benign prostatic hyperplasia
ApplicantUrotronic, Inc.
2495 Xenium Lane
Minneapolis, MN 55449
PMA NumberP220029
Date Received12/12/2022
Decision Date06/30/2023
Product Code QXB 
Docket Number 23M-2744
Notice Date 07/07/2023
Advisory Committee Gastroenterology/Urology
Clinical TrialsNCT04131907
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Optilume BPH Catheter System indicated for the treatment of obstructive urinary symptoms associated with Benign Prostatic Hyperplasia (BPH) in men >= 50 years of age.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 
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