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U.S. Department of Health and Human Services

Product Classification
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Device stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb
Definition As an aid in the management of chronic intractable phantom limb post amputation pain and pain in the residual limb post amputation.
Physical State Main components include implanted leads, implanted neurostimulator, and external programmers and external controller
Technical Method Uses electrical stimulation to stimulate the nerve terminus or neuroma
Target Area Nerve terminus or neuroma at amputated limb
Review Panel Neurology
Product CodeSAZ
Premarket Review Neuromodulation and Physical Medicine Devices (DHT5B)
Neuromodulation and Physical Medicine 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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