Device Type ID | 4441 |
Device Name | Ring, Endocapsular |
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 | MRJ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4441 |
Device | Ring, Endocapsular |
Product Code | MRJ |
FDA Device Classification | Class 3 Medical Device |
Device Problems | |
---|---|
Ring | 1 |
Defective Device | 1 |
Total Device Problems | 2 |