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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device vessel guard or cover, to facilitate revision surgeries
Regulation Description Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
Definition Wrap, patch, or cover intended to protect vessels from injury during surgery, with the secondary function of facilitating revision surgeries by providing a plane of dissection.
Product CodeMFX
Regulation Number 870.3470
Device Class 2


Premarket Reviews
ManufacturerDecision
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Unknown (for use when the device problem is not known) 8
Total Device Problems 8

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