Definition: Surgical Treatment Of Male Stress Urinary Incontinence Post-prostatectomy
| Device Type ID | 2176 |
| Device Name | Mesh, Surgical, For Stress Urinary Incontinence, Male |
| Physical State | Biologic (e.g., Collagen) And/or Synthetic (e.g, Metallic Or Polymeric) Woven Fabric Of Varying Design And Material Properties |
| Technical Method | Permanently Implantable Sling Placed Under The Urethra; During Instances Of Increased Abdominal Pressure (e.g., Coughing, Laughing, Sneezing, Etc.), Device Applies Pressure To The Urethra To Prevent Urine Leakage |
| Target Area | Bladder, Urethra |
| 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) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.3300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OTM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2176 |
| Device | Mesh, Surgical, For Stress Urinary Incontinence, Male |
| Product Code | OTM |
| 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 | |
| Device Problems | |
|---|---|
Insufficient Information | 155 |
Adverse Event Without Identified Device Or Use Problem | 38 |
Surgical Graft | 14 |
Malposition Of Device | 6 |
Migration Or Expulsion Of Device | 5 |
Torn Material | 4 |
Break | 3 |
Device Operates Differently Than Expected | 2 |
Use Of Device Problem | 2 |
Unexpected Therapeutic Results | 1 |
Migration | 1 |
Mechanical Problem | 1 |
Defective Device | 1 |
Device Or Device Fragments Location Unknown | 1 |
Detachment Of Device Or Device Component | 1 |
Needle | 1 |
Difficult To Insert | 1 |
Trocar | 1 |
| Total Device Problems | 238 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | American Medical Systems, Inc. | II | Dec-16-2014 |