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U.S. Department of Health and Human Services

Product Classification

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Device mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed
Regulation Description Surgical mesh.
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.
Physical State synthetic woven or non-woven fabric of varying material properties (e.g., resorption, density, pore size, weave, etc.); design can be pre-configured for specific repair or can be a sheet to allow surgeon to cut mesh to desired size and shape
Technical Method permanent implant placed transvaginally that provides mechanical support for weakened tissues of the pelvic floor
Target Area vagina, pelvic floor, uterus
Regulation Medical Specialty General & Plastic Surgery
Review Panel Obstetrics/Gynecology
Product CodeOTP
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Obstetrics and Gynecology Devices Branch (OGDB)
Submission Type 510(k)
Regulation Number 878.3300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh; Final
Third Party Review Not Third Party Eligible
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