OTP

Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

Product code

OTP

Device name

Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

Device class

Class 3

21 CFR

21 CFR 884.5980

Medical specialty

Obstetrics/Gynecology

Marketing pathway

PMA

Flag

Implant

510(k) clearances (all years, FDA)

31 (all years; only the last 3 years are listed here)

FDA classification definition

Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; Procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical or uterine prolapse repair performed transvaginally

Definition text from the FDA device classification database (U.S. federal government work, public domain).