| Device |
transcatheter septal occluder (ventricular) |
| Definition |
For the treatment of defect in the ventricular septum and closure of ventricular septal defects via transcatheter technique. |
| Physical State |
permanent implant placed in septum, usually constructed of a combination of metals/polymers that is placed via a catheter system |
| Technical Method |
percutaneous puncture and interventional technique |
| Target Area |
cardiac ventricular septum |
| Review Panel |
Cardiovascular |
|---|
| Product Code | OZH |
|---|
| Submission Type |
PMA
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
