| Device Type ID | 4446 |
| Device Name | Prosthesis, Retinal |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Contact Lenses And Retinal Devices Branch (CLRD) |
| Submission Type | HDE - Humanitarian Device Exem |
| FDA Device Classification | Class HDE Medical Device |
| Product Code | NBF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4446 |
| Device | Prosthesis, Retinal |
| Product Code | NBF |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 75 |
Wireless Communication Problem | 3 |
No Device Output | 2 |
Device Inoperable | 1 |
| Total Device Problems | 81 |