Prepex is sold and used in (b)(6), it is neither sold nor used in the usa.Receiving reports regarding aes is very challenging and the company makes every effort to gain as much information as possible.The company did not begin reporting any aes to the fda until it was demanded by the fda.As a result there is a gap between the time of the ae and the reporting.This issue will resolve itself during 2017 when the company will report to the fda as required and requested.On (b)(6) 2016: this is a corrected version of the file which was errouniously sent as a 5 day and not initial.The 5 day box has been cleared.Thank you.The original number of the submission was 00877 at the end but i couldn't resubmit a duplicate file so i changed the number to 8771 at the end.Device unavailable.
|