Definition: Bridging Material To Attach The Vaginal Apex To The Anterior Longitudinal Ligament Of The Sacrum; Procedures Include Abdominal Sacrocolpopexy And Laparoscopic Sacrocolpopexy.
| Device Type ID | 4105 |
| Device Name | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed |
| 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 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 | OTO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4105 |
| Device | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed |
| Product Code | OTO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Mesh. |
| CFR Regulation Number | 878.3300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CALDERA MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CALDERA MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
COLOPLAST MANUFACTURING US LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Migration Or Expulsion Of Device | 197 |
Adverse Event Without Identified Device Or Use Problem | 162 |
Appropriate Term/Code Not Available | 60 |
Insufficient Information | 38 |
Material Erosion | 31 |
Migration | 23 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 21 |
Torn Material | 10 |
Defective Device | 2 |
Unsealed Device Packaging | 2 |
Patient-Device Incompatibility | 2 |
Extrusion | 2 |
Explanted | 1 |
No Apparent Adverse Event | 1 |
Detachment Of Device Or Device Component | 1 |
Nonstandard Device | 1 |
| Total Device Problems | 554 |