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 |