Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
OTP · Class III — High Risk (PMA approval required, life-sustaining) · Obstetrics/Gynecology · 21 CFR 884.5980
Classification
FDA Product Code
OTP
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
21 CFR 884.5980
Review panel
OB
Medical specialty
Obstetrics/Gynecology
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
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