Lipoprotein, Low Density, Removal

Device Code: 2211

Product Code(s): MMY

Device Classification Information

Device Type ID2211
Device NameLipoprotein, Low Density, Removal
Review PanelGastroenterology/Urology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Renal Devices Branch (RNDB)
Submission TypePMA
FDA Device ClassificationClass 3 Medical Device
Product CodeMMY
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2211
DeviceLipoprotein, Low Density, Removal
Product CodeMMY
FDA Device ClassificationClass 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
TPLC Last Update: 2019-04-02 20:07:49

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