FWIW my opinion is really all I share but the FDA has a typical 180 turn around protocol for approving PMA's and the substantive review phase is the first which establishes to the submitter their application has been received and meets underlying requirements for their consideration! (What a bunch of bs government regulation!!) YES but the only avenue for medical product's to be blessed as safe to the public and stamped APPROVED BY FDA! All this said we hope the eSTAR process and our previous history does expedite this to a 45 day turnround? We will see?
$5-$10+