Definition: For The Treatment Of Defects In The Atrial Septum And Closure Of Atrial Septal Defects Via Transcatheter Technique.
| Device Type ID | 1074 |
| Device Name | Transcatheter Septal Occluder (atrial) |
| Physical State | Permanent Implant Placed In Septum (usually Constructed Of A Combination Of Metals/polymers That Is Placed Via A Venous Catheter System) |
| Technical Method | Percutaneous Venous Puncture And Interventional Technique |
| Target Area | Cardiac Atrial Septum |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | OZG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1074 |
| Device | Transcatheter Septal Occluder (atrial) |
| Product Code | OZG |
| FDA Device Classification | Class 3 Medical Device |