Definition: For Coarctation Of The Aorta
Device Type ID | 1082 |
Device Name | Stent Delivery System |
Physical State | For Coarctation Of The Aorta |
Technical Method | For Coarctation Of The Aorta |
Target Area | Aorta |
Review Panel | Cardiovascular |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Interventional Cardiology Devices Branch (ICDB) |
Submission Type | Enforcement Discretion |
FDA Device Classification | Class Not Classified Medical Device |
Product Code | PKK |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1082 |
Device | Stent Delivery System |
Product Code | PKK |