Definition: Coarctation Of The Aorta
Device Type ID | 1083 |
Device Name | Aortic Stent |
Physical State | The Stent Is Metal And Is Offered In A Range Of Diameters |
Technical Method | An Expandable Stent Is Placed In The Aorta To Keep The Vessel Open |
Target Area | Aorta |
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 | PNF |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | Yes |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1083 |
Device | Aortic Stent |
Product Code | PNF |
FDA Device Classification | Class 3 Medical Device |