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Re: DR5 post# 13420

Friday, 04/05/2024 10:48:10 AM

Friday, April 05, 2024 10:48:10 AM

Post# of 13776
Complete manipulation of the information DR5.
The guidelines are clear. You have simply pasted what a simpleton wants to see. So of course Trust is following your backward logic.

Do real homework and you can see from the FDA website:

FDA Action On a PMA
Within 180 days of the date of filing of the PMA (§814.40), FDA will complete its review of the PMA and of the advisory committee`s report and recommendation and issue one of the following:

an approval order under §814.44(d),
an approvable letter under §814.44(e),
a not approvable letter under §814.44(f), or
an order denying approval under §814.45.