PMSNR

The FDA premarket submission number of those products requiring premarket approval or notification before being marketed in the U.S., including medical devices and products with medical device constituents regulated by CDER, CBER and CDRH. Petition number for devices granted marketing authorization via a De Novo petition is also accepted in the FDA Premarket Submission Number field. Submission types included are 510(k), De Novo, PMA, PDP, HDE, BLA, ANDA and NDA.