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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device percutaneous nerve stimulator for opioid withdrawal
Definition Stimulate nerve branches to aid in the reduction of symptoms associated with substance use disorders.
Product CodePZR
Regulation Number 882.5896
Device Class 2


Premarket Reviews
ManufacturerDecision
DYANSYS, INC.
  SUBSTANTIALLY EQUIVALENT 3
INNOVATIVE HEALTH SOLUTIONS (IHS), INC.
  GRANTED 1
SPARK BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

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