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U.S. Department of Health and Human Services

Product Classification

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Device stimulator, intracerebral/subcortical, implanted
Regulation Description Implanted intracerebral/subcortical stimulator for pain relief.
Definition Call for PMAs to be filed by 3/1/89 per 53 FR 43621 on 12/1/88
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGYZ
Premarket Review Neuromodulation and Rehabilitation Devices (DHT5B)
Neuromodulation and Rehabilitation Devices (DHT5B)
Submission Type PMA
Regulation Number 882.5840
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
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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