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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device biliary stent system for benign strictures
Regulation Description Metallic biliary stent system for benign strictures.
Definition A benign stricture biliary stent system is a prescription device intended for treatment of benign biliary strictures. Stents are intended to be left indwelling for a limited amount of time and subsequently removed. The device consists of a metal stent and a delivery system intended to place the stent in the biliary ducts.
Product CodePNB
Regulation Number 876.5011
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  GRANTED 1

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