| Device Type ID | 2185 |
| Device Name | Prosthesis, Urethral Sphincter |
| 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 | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | FAG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2185 |
| Device | Prosthesis, Urethral Sphincter |
| Product Code | FAG |
| FDA Device Classification | Class 3 Medical Device |