Bulkamid Urethral Bulking System

FDA premarket approval P170023 · Agent, Bulking, Injectable for Gastro-Urology Use

PMA numberP170023

Approval

Applicant
Boston Scientific Corporation
Received
July 31, 2017
Decision date
January 28, 2020 (APPR)
Supplements
21, latest July 1, 2026
Product code
LNM – Agent, Bulking, Injectable For Gastro-Urology Use

Official FDA PMA record

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.