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 |