Definition: The Device Is A Passive Mesh Wrap That Is Placed Around Both Ventricles Of The Heart; The Intention Is To Inhibit Further Dilatation Of The Ventricles And Thus To Facilitate Reverse Remodeling Of The Myocardium. The Device Is Indicated For Use In Adu
| Device Type ID | 1042 |
| Device Name | Cardiac Support Mesh Wrap |
| Physical State | The Device Is A Passive Mesh Wrap That Is Placed Around Both Ventricles Of The Heart; The Intention Is To Inhibit Further Dilatation Of The Ventricles And Thus To Facilitate Reverse Remodeling Of The Myocardium. The Device Is Indicated For Use In Adu |
| Technical Method | The Device Is A Passive Mesh Wrap That Is Placed Around Both Ventricles Of The Heart; The Intention Is To Inhibit Further Dilatation Of The Ventricles And Thus To Facilitate Reverse Remodeling Of The Myocardium. The Device Is Indicated For Use In Adu |
| Target Area | Heart |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Circulatory Support Devices Branch (CSDB) |
| Submission Type | Contact ODE |
| FDA Device Classification | Class Not Classified Medical Device |
| Product Code | NAP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1042 |
| Device | Cardiac Support Mesh Wrap |
| Product Code | NAP |