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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceProVee System for BPH
Generic NameSTENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
ApplicantProverum, Ltd.
2nd Floor Astor Hall, 4-8 Eden Quay
Dublin D01N5
PMA NumberP250011
Date Received04/02/2025
Decision Date12/09/2025
Product Code MER 
Advisory Committee Gastroenterology/Urology
Clinical TrialsNCT05186740
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The ProVee System for BPH is intended for the treatment of obstructive lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH) in men with prostatic urethral lengths greater than or equal to 3.75 cm and prostatic volumes between 30 and 80 cc.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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