Definition: An Absorbable Scaffold With A Drug Coating Placed Via A Delivery Catheter Into The Coronary Artery Or Saphenous Vein Graft To Maintain The Lumen. The Drug Coating Is Intended To Inhibit Restenosis.
| Device Type ID | 1084 |
| Device Name | Absorbable Coronary Drug-eluting Stent |
| Physical State | Mesh Tube In Various Lengths And Diameters |
| Technical Method | Provides Mechanical Support To The Treated Artery And A Drug Agent To Prevent Restenosis Of The Treated Artery, And Then Gradually Dissolves And Is Absorbed By The Body. |
| Target Area | Coronary Arteries |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Interventional Cardiology Devices Branch (ICDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PNY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1084 |
| Device | Absorbable Coronary Drug-eluting Stent |
| Product Code | PNY |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 35 |
Improper Or Incorrect Procedure Or Method | 4 |
Patient-Device Incompatibility | 2 |
Material Separation | 1 |
Device Damaged By Another Device | 1 |
| Total Device Problems | 43 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abbott Vascular | I | Jun-01-2017 |