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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device surgical film
Regulation Description Surgical mesh.
Definition To be implanted to reinforce soft tissue or bone where weakness exists. Intended to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological, or gastrointestinal anatomy, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. The absorbable protective film also may help minimize the potential for tissue attachment to the device in case of direct contact with the viscera.
Product CodeOOD
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
TEPHA, INC.
  SUBSTANTIALLY EQUIVALENT 7

Device Problems
No Information 8
Incorrect or inadequate result 2
Torn material 1
Not Applicable 1
Hole in material 1
Total Device Problems 13

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