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TPLC - Total Product Life Cycle
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TPLC
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Device
stimulator, peripheral nerve, non-implanted, for pelvic floor dysfunction
Regulation Description
Nonimplanted, peripheral electrical continence device.
Product Code
NAM
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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