Does this help? From the FDA SSED, June 2021 expanded use approval
Results from the retrospective study provide sufficient initial evidence to support a 6-month shelf life for the RECELL® Device (based on available stability data provided for the activity of the Enzyme component). A prospective study assessing Enzyme stability will be performed to support future extension of the current 18-month shelf-life.
Does this help? From the FDA SSED, June 2021 expanded use...
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