Transmedics Inc 200 Minuteman Road Suite 302andover Ma 01810 Pma Numberp180051 Supplement Numbers001 Date Received11 08 2021 Decision Date04 27 2022 Product Code Qik Advisory Committee Cardiovascular Clinical Trialsnct03831048 Supplement Typepanel Track Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Transmedics Inc 200 Minuteman Road Suite 302andover Ma 01810 Pma Numberp180051 Supplement Numbers001 Date Received11 08 2021 Decision Date04 27 2022 Product Code Qik Advisory Committee Cardiovascular Clinical Trialsnct03831048 Supplement Typepanel Track Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename Expedited Review Granted No. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Filings

Device Company	Device	Date
PMA P180051S001 TransMedics, Inc.200 Minuteman Road, Suite 302andover, MA 01810 PMA NumberP180051 Supplement NumberS001 Date Received11/08/2021 Decision Date04/27/2022 Product Code QIK  Advisory Committee Cardiovascular Clinical TrialsNCT03831048 Supplement Typepanel Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	OCS Heart System	2022-04-27