| Device Type ID | 1034 |
| Device Name | Intravascular Radiation Delivery System |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Interventional Cardiology Devices Branch (ICDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MOU |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1034 |
| Device | Intravascular Radiation Delivery System |
| Product Code | MOU |
| FDA Device Classification | Class 3 Medical Device |