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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device shunt, peritoneal
Regulation Description Peritoneo-venous shunt.
Product CodeKPM
Regulation Number 876.5955
Device Class 2


Premarket Reviews
ManufacturerDecision
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 3
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
DENVER BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 8

Device Problems
Device remains implanted 1
Total Device Problems 1

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