Definition: Bridging Material To Attach The Vaginal Apex Or Uterus To The Sacral Promontory; Procedures Include Abdominal Sacrocolpopexy, Laparoscopic Sacrocolpopexy And Robot-assisted Sacrocolpopexy.
| Device Type ID | 4106 |
| Device Name | Mesh, Surgical, Non-synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed |
| 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 Transabdominally That Provides Mechanical Support And/or Serves As A Bridging Material For Suspending The Vaginal Apex Or Uterus To The Sacral Promontory. |
| Target Area | Vagina, Uterus, Sacrum |
| Regulation Description | Surgical Mesh. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | Obstetrics/Gynecology |
| 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 | PAJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4106 |
| Device | Mesh, Surgical, Non-synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed |
| Product Code | PAJ |
| 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 | 475 |
Device Packaging Compromised | 2 |
Torn Material | 1 |
| Total Device Problems | 478 |