Entac Medical, Inc. 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
PrevisEA Device510(k)May 19, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 19, 2023
PrevisEA Device510(k)Aug 4, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 4, 2021