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U.S. Department of Health and Human Services

Product Classification
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Device stimulator, neuromuscular, implanted
Regulation Description Implanted neuromuscular stimulator.
Definition Call for PMAs to be filed by 7/13/99 per 64 FR 18329 on 4/14/99
Regulation Medical Specialty Neurology
Review Panel Physical Medicine
Product CodeGZC
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Rehabilitation Devices (DHT5B)
Submission Type PMA
Regulation Number 882.5860
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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