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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device temporarily implanted peripheral nerve stimulation system for sustained pain relief
Regulation Description Implanted peripheral nerve stimulator for pain relief.
Definition A temporarily implanted peripheral nerve stimulation system for sustained pain relief is a prescription device that uses an external electrical stimulator(s) and percutaneous electrode(s) to stimulate a peripheral nerve(s) to provide sustained pain relief after the end of treatment.
Product CodeSCN
Regulation Number 882.5870
Device Class 2


Premarket Reviews
ManufacturerDecision
SPR THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

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