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U.S. Department of Health and Human Services

Product Classification
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Device dorsal root ganglion stimulator for pain relief
Definition Stimulation of the dorsal root ganglion for the treatment of chronic, intractable pain of the lower limbs.
Physical State Main components include implanted leads, implanted neurostimulator, and external programmers
Technical Method Uses electrical stimulation to the dorsal root ganglion to relieve chronic, intractable pain
Target Area dorsal root ganglion
Review Panel Neurology
Product CodePMP
Premarket Review Neuromodulation and Rehabilitation Devices (DHT5B)
Neuromodulation and Rehabilitation Devices (DHT5B)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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