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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, peripheral nerve, non-implanted, for pelvic floor dysfunction
Regulation Description Nonimplanted, peripheral electrical continence device.
Product CodeNAM
Regulation Number 876.5310
Device Class 2

Device Problems
Adverse Event Without Identified Device or Use Problem 76
Device Operates Differently Than Expected 4
Failure to Deliver Energy 2
Positioning Problem 1
Material Deformation 1
Total Device Problems 84


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