Electrode, Spinal Epidural

Device Code: 3738

Product Code(s): LHG

Device Classification Information

Device Type ID3738
Device NameElectrode, Spinal Epidural
Regulation DescriptionImplanted Spinal Cord Stimulator For Pain Relief.
Regulation Medical SpecialtyNeurology
Review PanelNeurology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Neurological And Physical Medicine Devices (DNPMD)
Neurodiagnostic And Neurosurgical Devices Branch (NDNB)
Submission Type510(k)
CFR Regulation Number882.5880 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeLHG
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3738
DeviceElectrode, Spinal Epidural
Product CodeLHG
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionImplanted Spinal Cord Stimulator For Pain Relief.
CFR Regulation Number882.5880 [🔎]
TPLC Last Update: 2019-04-02 20:35:45

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