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.
| Device Type ID | 4075 |
| Device Name | Mesh, Surgical, Non-synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally 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 Transvaginally That Provides Mechanical Support For Weakened Tissues Of The Pelvic Floor. |
| Target Area | Vagina, Pelvic Floor, Uterus |
| Regulation Description | Surgical Mesh For Transvaginal Pelvic Organ Prolapse Repair. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| 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 | PMA |
| CFR Regulation Number | 884.5980 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PAI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4075 |
| Device | Mesh, Surgical, Non-synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
| Product Code | PAI |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Surgical Mesh For Transvaginal Pelvic Organ Prolapse Repair. |
| CFR Regulation Number | 884.5980 [🔎] |
| Device Problems | |
|---|---|
Insufficient Information | 5 |
Extrusion | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 7 |