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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device collagen surgical mesh containing drugs
Regulation Description Surgical mesh.
Definition Reinforcement of soft tissue where weakness exists.
Product CodePIJ
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Material disintegration 1
No Information 1
Total Device Problems 2

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