Transmedics Inc200 Minuteman Roadsuite 302andover Ma 01810 Pma Numberp160013 Supplement Numbers009 Date Received02 07 2022 Decision Date05 06 2022 Product Codes Pho Qba Advisory Committee Gastroenterology Urology Supplement Typereal Time Process Supplement Reason Change Design Components Specifications Material Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Transmedics Inc200 Minuteman Roadsuite 302andover Ma 01810 Pma Numberp160013 Supplement Numbers009 Date Received02 07 2022 Decision Date05 06 2022 Product Codes Pho Qba Advisory Committee Gastroenterology Urology Supplement Typereal Time Process Supplement Reason Change Design Components Specifications Material 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 P160013S009 TransMedics, Inc200 Minuteman Roadsuite 302andover, MA 01810 PMA NumberP160013 Supplement NumberS009 Date Received02/07/2022 Decision Date05/06/2022 Product Codes PHO QBA  Advisory Committee Gastroenterology/Urology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No	Organ Care System™ (OCS) Lung System	2022-05-06