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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.
 
DeviceBulkamid Urethral Bulking System
Generic Nameagent, bulking, injectable for gastro-urology use
Applicant
Contura International A/S
sydmarken 23
soeborg 2860
PMA NumberP170023
Date Received07/31/2017
Decision Date01/28/2020
Product Code LNM 
Docket Number 20M-0495
Notice Date 01/30/2020
Advisory Committee Gastroenterology/Urology
Clinical Trials NCT00333073
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Bulkamid Urethral Bulking System. The device is indicated for urethral injection for the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) in adult women who have SUI or stress predominant mixed incontinence.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Supplements:  S001 S003 
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