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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 Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Physical Medicine and Rehabilitation Devices Branch (PMDB)
Submission Type PMA
Regulation Number 882.5860
Device Class 3
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