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U.S. Department of Health and Human Services

Product Classification

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Device stimulator, spinal-cord, implanted (pain relief)
Regulation Description Implanted spinal cord stimulator for pain relief.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGZB
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurostimulation Devices Branch (NSDB)
Submission Type 510(k)
Regulation Number 882.5880
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible