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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 Urethral Drug Coated Balloon
Generic NameCatheter, Balloon, Urethral, Drug-Coated
ApplicantUrotronic, Inc.
2495 Xenium Lane
Minneapolis, MN 55441
PMA NumberP210020
Date Received05/11/2021
Decision Date12/03/2021
Product Code QRH 
Docket Number 21M-1284
Notice Date 12/09/2021
Advisory Committee Gastroenterology/Urology
Clinical TrialsNCT03014726
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval of the Optilume® Urethral Drug Coated Balloon. The device is used to treat patients with obstructive urinary symptoms associated with anterior urethral stricture. It is designed to be used in adult males for urethral strictures of less than or equal to 3 cm in length.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S008 S009 
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