Definition: Transvaginal Surgical Repair Of Female Stress Urinary Incontinence (SUI) Due To Intrinsic Sphincter Deficiency (ISD) And/or Urethral Hypermobility.
| Device Type ID | 2179 |
| Device Name | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling |
| 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 Shape. |
| Technical Method | With A Single Vaginal Incision, The Sling Is Placed Under The Urethra; 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 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 | PAH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2179 |
| Device | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling |
| Product Code | PAH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Mesh. |
| CFR Regulation Number | 878.3300 [🔎] |
| Device Problems | |
|---|---|
Insufficient Information | 189 |
Adverse Event Without Identified Device Or Use Problem | 143 |
Migration Or Expulsion Of Device | 42 |
Positioning Failure | 25 |
Material Erosion | 23 |
Appropriate Term/Code Not Available | 21 |
Extrusion | 19 |
Break | 18 |
Tip | 17 |
Bent | 11 |
Migration | 8 |
Material Protrusion / Extrusion | 6 |
Material Twisted / Bent | 5 |
Detachment Of Device Component | 4 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 4 |
Detachment Of Device Or Device Component | 3 |
Premature Activation | 3 |
Carrier | 3 |
Surgical Graft | 3 |
Patient-Device Incompatibility | 2 |
Device Operates Differently Than Expected | 2 |
Deformation Due To Compressive Stress | 2 |
Entrapment Of Device | 2 |
Material Deformation | 2 |
Tape | 1 |
Device Packaging Compromised | 1 |
Loose Or Intermittent Connection | 1 |
Difficult To Advance | 1 |
Missing Value Reason | 1 |
Device Slipped | 1 |
Activation, Positioning Or Separation Problem | 1 |
Device Dislodged Or Dislocated | 1 |
Fracture | 1 |
Unexpected Therapeutic Results | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
| Total Device Problems | 568 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Astora | II | Nov-16-2015 |