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.

• Device: Bulkamid Urethral Bulking System
• Generic Name: Agent, Bulking, Injectable For Gastro-urology Use
• Applicant: Contura International A/S
• Date Received: 2017-07-31
• Decision Date: 2020-01-28
• PMA: P170023
• Supplement: S
• Product Code: LNM
• Advisory Committee: Gastroenterology/Urology
• Expedited Review: No
• 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 Number	Date	Supplement Type
P170023		Original 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 ID	PMA	Supp
05704101500500	P170023	000
10810005340493	P170023	015