Additional information was added to d9, h3, h4, h6, h10.H4: the lot was manufactured between august 21, 2020 to august 24, 2020.H10: two (2) devices were received for evaluation.Unaided eye visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed with no issues noted.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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