| Device Type ID | 1022 |
| Device Name | Occluder, Patent Ductus, Arteriosus |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Structural Heart Devices Branch (SHDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MAE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1022 |
| Device | Occluder, Patent Ductus, Arteriosus |
| Product Code | MAE |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Material Deformation | 10 |
Unintended Movement | 10 |
Migration Or Expulsion Of Device | 7 |
Use Of Device Problem | 6 |
Adverse Event Without Identified Device Or Use Problem | 5 |
Insufficient Information | 5 |
Inadequacy Of Device Shape And/or Size | 4 |
Activation, Positioning Or Separation Problem | 3 |
Leak / Splash | 2 |
Premature Activation | 2 |
Detachment Of Device Or Device Component | 1 |
Difficult To Insert | 1 |
Hole In Material | 1 |
Material Separation | 1 |
Material Protrusion / Extrusion | 1 |
Device Dislodged Or Dislocated | 1 |
Appropriate Term/Code Not Available | 1 |
Unintended Ejection | 1 |
Retraction Problem | 1 |
Perivalvular Leak | 1 |
Difficult To Remove | 1 |
Device Operates Differently Than Expected | 1 |
Fracture | 1 |
Unstable | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Failure To Advance | 1 |
| Total Device Problems | 70 |