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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
Regulation Description Assisted reproduction laser system.
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 BIOSCIENCES
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 2
MINITUBE OF AMERICA, INC
  SUBSTANTIALLY EQUIVALENT 1
RESEARCH INSTRUMENTS LTD.
  SUBSTANTIALLY EQUIVALENT 3

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