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U.S. Department of Health and Human Services

Product Classification

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Device stimulator, spinal-cord, implanted, for bladder evacuation
Regulation Description Implanted spinal cord stimulator for bladder evacuation.
Definition Call for pmas to be filed by 12/26/96 per 61 fr 50708 on 9/27/96.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGZD
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 882.5850
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