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

FDA product code OTP · 31 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
2003-12-31 – 2012-12-13

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

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