Definition: Transvaginal Surgical Repair Of Female Stress Urinary Incontinence (SUI) Due To Intrinsic Sphincter Deficiency (ISD) And/or Urethral Hypermobility.
| Device Type ID | 2178 |
| Device Name | Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| 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 Or Can Be A Sheet To Allow Surgeon To Cut The Mesh To Desired Size And Shape. |
| 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 |
| Target Area | Urethra, Vagina |
| Regulation Description | Surgical Mesh. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | Gastroenterology/Urology |
| 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) |
| CFR Regulation Number | 878.3300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PAG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2178 |
| Device | Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Product Code | PAG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Mesh. |
| CFR Regulation Number | 878.3300 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 42 |
Insufficient Information | 12 |
Device Operates Differently Than Expected | 2 |
| Total Device Problems | 56 |