Definition: Stent, Coronary, Covered -- A Metal Scaffold Covered With Material Placed Via A Delivery Catheter Into The Coronary Artery Artery Or Saphenous Vein Graft For The Treatment Of Free Perforations And/or To Prevent Dislodgement Into The Circulation Of Bi
| Device Type ID | 1052 |
| Device Name | Coronary Covered Stent |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Interventional Cardiology Devices Branch (ICDB) |
| Submission Type | HDE - Humanitarian Device Exem |
| FDA Device Classification | Class HDE Medical Device |
| Product Code | NIV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
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| Device Type ID | 1052 |
| Device | Coronary Covered Stent |
| Product Code | NIV |