Definition: Call For PMAs On 7/5/95 Per 60 FR 17216 On 4/5/95
| Device Type ID | 1720 |
| Device Name | Prosthesis, Testicular |
| Regulation Description | Testicular Prosthesis. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| 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 |
| CFR Regulation Number | 876.3750 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | FAF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1720 |
| Device | Prosthesis, Testicular |
| Product Code | FAF |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Testicular Prosthesis. |
| CFR Regulation Number | 876.3750 [🔎] |
| Device Problems | |
|---|---|
Deflation Problem | 2 |
Migration Or Expulsion Of Device | 1 |
Leak / Splash | 1 |
Break | 1 |
Insufficient Information | 1 |
| Total Device Problems | 6 |