• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed
Regulation Description Surgical mesh.
Definition Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy.
Physical State synthetic woven or non-woven fabric of varying material properties (e.g., density, pore size, weave, resorption, 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 transabdominally that provides mechanical support and/or serves as a bridging material for suspending the vaginal apex or uterus from the sacral promontory.
Target Area vagina, uterus, sacrum
Regulation Medical Specialty General & Plastic Surgery
Review Panel Obstetrics/Gynecology
Product CodeOTO
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
-
-