Device Type ID | 4447 |
Device Name | Telescope, Implantable, Miniature |
Review Panel | Ophthalmic |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Intraocular And Corneal Implants Devices Branch (ICIB) |
Submission Type | PMA |
FDA Device Classification | Class 3 Medical Device |
Product Code | NCJ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4447 |
Device | Telescope, Implantable, Miniature |
Product Code | NCJ |
FDA Device Classification | Class 3 Medical Device |
Device Problems | |
---|---|
Insufficient Information | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Break | 1 |
Total Device Problems | 5 |