Prolira B.V. FDA Approvals

0 new drug approvals and 2 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
DeltaScan Patch510(k)Feb 2, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Feb 2, 2023
DeltaScan Monitor510(k)Feb 2, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Feb 2, 2023