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

FDA product code PAI · 2 cleared devices

Class 3 Obstetrics/Gynecology
Regulation
21 CFR 884.5980
Review panel
OB
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2005-03-09 – 2013-04-05

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 and uterine prolapse repair completed transvaginally.

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