Transmedics Inc 200 Minuteman Roadsuite 302andover Ma 01810 Pma Numberp200031 Supplement Numbers001 Date Received04 08 2022 Decision Date09 19 2022 Product Code Qqk Advisory Committee Gastroenterology Urology Clinical Trialsnct02522871 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change Pas Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Transmedics Inc 200 Minuteman Roadsuite 302andover Ma 01810 Pma Numberp200031 Supplement Numbers001 Date Received04 08 2022 Decision Date09 19 2022 Product Code Qqk Advisory Committee Gastroenterology Urology Clinical Trialsnct02522871 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change Pas 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 P200031S001 TransMedics, Inc.200 Minuteman Roadsuite 302andover, MA 01810 PMA NumberP200031 Supplement NumberS001 Date Received04/08/2022 Decision Date09/19/2022 Product Code QQK  Advisory Committee Gastroenterology/Urology Clinical TrialsNCT02522871 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No	Organ Care System (OCS®) Liver™	2022-09-19