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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceZenflow Spring® Implant and Delivery System
Generic NameSTENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
ApplicantZenflow, Inc.
395 Oyster Point Blvd.
Suite 501
South San Francisco, CA 94080
PMA NumberP250007
Date Received03/11/2025
Decision Date12/11/2025
Product Code MER 
Docket Number FDA-7228
Notice Date 12/19/2025
Advisory Committee Gastroenterology/Urology
Clinical TrialsNCT02786290
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The Zenflow Spring Implant and Delivery System is indicated for the treatment of obstructive lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH) in men with prostatic urethral lengths between 25 and 45 mm and prostate sizes between 25 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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