| Device |
mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator |
| Regulation Description |
Surgical mesh. |
| Definition |
Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility |
| 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 or can be a sheet to allow surgeon to cut mesh to desired size and shap |
| Technical Method |
placed under the urethra transvaginally using a transobturator (one vaginal incision and two groin/upper thigh incisions) or retropubic (one vaginal incision and two abdominal incisions) approach; during instances of increased abdominal pressure (e.g., coughing, laughing, sneezing, etc.) the device applies pressure to the urethra to prevent urine leakage |
| Target Area |
urethra, vagina |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
Gastroenterology/Urology |
|---|
| Product Code | OTN |
|---|
| Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.3300
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
|
|
