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SC8

02/07/23 10:53 AM

#157060 RE: wrinklesobw #157057

4th meeting reviewing another incomplete draft IDE is hopefully a non-event with FDA suggesting no further testing beyond the additional animal testing that hasn't started yet.

rtg123

02/07/23 10:59 AM

#157063 RE: wrinklesobw #157057

For standard request ~ 60 days
For accelerated request ~ 30 days

So the meeting to get feedback on the draft IDE could be at the end of the month.