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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.
https://www.fda.gov/medical-devices/premarket-approval-pma/pma-review-process#steps
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