| Device |
mesh, surgical, non-synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed |
| Regulation Description |
Surgical mesh for transvaginal pelvic organ prolapse repair. |
| 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 and uterine prolapse repair completed transvaginally. |
| Physical State |
Non-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 the 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 |
Obstetrics/Gynecology |
| Review Panel |
Obstetrics/Gynecology |
|---|
| Product Code | PAI |
|---|
| Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
| Submission Type |
PMA
|
|---|
| Regulation Number |
884.5980
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
|
|
