Mcgovern Medical School 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
Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4510(k)Aug 21, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 21, 2023
Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3510(k)Apr 12, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 12, 2021