Stimulator, Spinal-cord, Implanted For Peripheral Vascular Disease

Device Code: 3834

Product Code(s): LLE

Device Classification Information

Device Type ID3834
Device NameStimulator, Spinal-cord, Implanted For Peripheral Vascular Disease
Review PanelNeurology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Neurological And Physical Medicine Devices (DNPMD)
Neurostimulation Devices Neurology Branch (NSDN)
Submission TypeContact ODE
FDA Device ClassificationClass 3 Medical Device
Product CodeLLE
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3834
DeviceStimulator, Spinal-cord, Implanted For Peripheral Vascular Disease
Product CodeLLE
FDA Device ClassificationClass 3 Medical Device
TPLC Last Update: 2019-04-02 20:38:04

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