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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
ApplicantAxonics Modulation Technologies, Inc.
26 technology drive
irvine, CA 92618
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 TrialsNCT00333073
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 S003 S005 S007 S008 S009 S010 S011 S012 S013 
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