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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gallbladder drainage stent and delivery system
Definition A gallbladder drainage stent is a prescription device intended to facilitate transgastric or transduodenal endoscopic drainage of the gallbladder. This device may also include a delivery system.
Product CodeQXH
Regulation Number 876.5016
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORPORATION
  GRANTED 1

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