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Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
- Page Type
- Product Code
- 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 and Plastic Surgery
- Review Panel
- Obstetrical and Gynecological
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 878.3300
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- Yes
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
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CFR § 878.3300 Surgical mesh
§ 878.3300 Surgical mesh.
(a) Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.
(b) Classification. Class II.