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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mesh, surgical, absorbable, abdominal hernia
Regulation Description Surgical mesh.
Definition For reinforcement of soft tissue where weakness exists during hernia repair.
Product CodeOWT
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
TEPHA, INC.
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect or inadequate result 2
Break 1
Material fragmentation 1
Total Device Problems 4

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