Bulkamid Urethral Bulking System

FDA Premarket Approval P170023

Pre-market Approval Supplement Details

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.

DeviceBulkamid Urethral Bulking System
Generic NameAgent, Bulking, Injectable For Gastro-urology Use
ApplicantContura International A/S
Date Received2017-07-31
Decision Date2020-01-28
PMAP170023
SupplementS
Product CodeLNM 
Advisory CommitteeGastroenterology/Urology
Expedited ReviewNo
Combination Product No
Applicant Address Contura International A/S sydmarken 23 soeborg 2860
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P170023Original Filing
S013 2022-09-27 30-day Notice
S012 2022-09-27 30-day Notice
S011 2022-07-08 30-day Notice
S010 2022-07-08 30-day Notice
S009 2022-07-08 30-day Notice
S008 2020-12-18 30-day Notice
S007 2020-11-24 30-day Notice
S006
S005 2020-09-04 Real-time Process
S004
S003 2020-08-13 Real-time Process
S002
S001 2020-05-05 30-day Notice

NIH GUDID Devices

Device IDPMASupp
05704101500500 P170023 000

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