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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
Regulation Description Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
Definition These device types do not include devices whose primary purpose is to minimize the incidence or severity of adhesion formation as a result of vascular surgery. Intended to protect vessels from injury during surgery (not to be confused with wraps, patches or covers intended to facilitate revision surgeries). Indicated to wrap, patch, or cover intended to cover blood vessels.
Product CodeOMR
Regulation Number 870.3470
Device Class 2


Premarket Reviews
ManufacturerDecision
REPLICATION MEDICAL INC
  SE - WITH LIMITATIONS 1
SPINEMEDICA, LLC
  SE - WITH LIMITATIONS 2
SYNTHES
  SE - WITH LIMITATIONS 2
XYLOS CORPORATION
  SE - WITH LIMITATIONS 1

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