Electrode, Stabilized Epidural Spinal

Device Code: 3831

Product Code(s): LHY

Device Classification Information

Device Type ID3831
Device NameElectrode, Stabilized Epidural Spinal
Review PanelNeurology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Neurological And Physical Medicine Devices (DNPMD)
Neurodiagnostic And Neurosurgical Devices Branch (NDNB)
Submission TypePMA
FDA Device ClassificationClass 3 Medical Device
Product CodeLHY
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3831
DeviceElectrode, Stabilized Epidural Spinal
Product CodeLHY
FDA Device ClassificationClass 3 Medical Device
TPLC Last Update: 2019-04-02 20:38:00

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