FDA Product Code OTN: Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

FDA product code OTN covers synthetic urogynecological mesh used for the surgical treatment of female stress urinary incontinence.

These synthetic polypropylene mesh tapes are placed under the mid-urethra through a minimally invasive approach to provide a supportive hammock that prevents urinary leakage during physical activity. Midurethral slings have become the standard surgical treatment for stress urinary incontinence.

OTN devices are Class II medical devices, regulated under 21 CFR 878.3300 and reviewed by the FDA Gastroenterology & Urology panel.

Leading manufacturers include American Medical Systems, Inc., Caldera Medical, Inc. and Ethicon, Inc..