| Device Type ID | 1030 |
| Device Name | Shunt, Portosystemic, Endoprosthesis |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Vascular Surgery Devices Branch (VSDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MIR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1030 |
| Device | Shunt, Portosystemic, Endoprosthesis |
| Product Code | MIR |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Patient-Device Incompatibility | 6 |
Insufficient Information | 3 |
Material Separation | 2 |
Patient Device Interaction Problem | 1 |
Complete Blockage | 1 |
Pressure Problem | 1 |
Malposition Of Device | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Occlusion Within Device | 1 |
Activation Failure Including Expansion Failures | 1 |
Stent | 1 |
Obstruction Of Flow | 1 |
Activation, Positioning Or Separation Problem | 1 |
| Total Device Problems | 21 |