| Device Type ID | 2211 |
| Device Name | Lipoprotein, Low Density, Removal |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Renal Devices Branch (RNDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MMY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2211 |
| Device | Lipoprotein, Low Density, Removal |
| Product Code | MMY |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 8 |
Patient Device Interaction Problem | 3 |
Use Of Device Problem | 2 |
Improper Or Incorrect Procedure Or Method | 1 |
| Total Device Problems | 14 |