Definition: A Metal Scaffold Placed Via A Delivery Catheter In The Iliac Vein To Maintain The Lumen
Device Type ID | 1087 |
Device Name | Stent, Iliac Vein |
Physical State | A Metal Scaffold Placed Via A Delivery Catheter |
Technical Method | A Metal Scaffold Placed Via A Delivery Catheter In The Iliac Vein To Maintain The Lumen |
Target Area | Iliac Vein |
Review Panel | Cardiovascular |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Peripheral Interventional Devices Branch (PIDB) |
Submission Type | PMA |
FDA Device Classification | Class 3 Medical Device |
Product Code | QAN |
GMP Exempt | No |
Summary MR | Ineligible |
Implanted Device | Yes |
Life Support Device | Yes |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1087 |
Device | Stent, Iliac Vein |
Product Code | QAN |
FDA Device Classification | Class 3 Medical Device |