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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, assisted reproduction laser
Definition This system is inteded to be used to drill a small tangential hole in or to thin the zona pellucida of the embryo in selected in vitro fertilization patients with otherwise poor prognois for successful pregnancy outcome, such as advanced maternal age, prior failed in vitro fertilization procedures, cryopreserved embryos, or abnormal zona pellucida morphology.
Product CodeMRX
Regulation Number 884.6200
Device Class 2


Premarket Reviews
ManufacturerDecision
HAMILTON THORNE, INC.
  SUBSTANTIALLY EQUIVALENT 2
RESEARCH INSTRUMENTS LTD.
  SUBSTANTIALLY EQUIVALENT 2
VITROLIFE GMBH
  SUBSTANTIALLY EQUIVALENT 1

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