Initial emdr is being re-submitted per request of fda on 29-apr-2021.Reported to the fda on 06-nov-2015 on 17-dec-2015, the following correction was identified: the report submitted on 06-nov-2015, with the patient identifier (b)(6), had the incorrect manufacturer report number listed 1722554-2015-31299.The correct manufacturers report number should have been 1049092-2015-31299.In addition, fields has been updated to reflect this correction.Please note, field has also been updated.Reported to the fda on 18-dec-2015.Fda registration number: reporting site: (b)(4).Manufacturing site: (b)(4).
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