Transmedics

FDA Filings

This page includes the latest FDA filings for Transmedics. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3003152463
• FEI Number: 3003152463
• Name: TRANSMEDICS, INC.
• Owner & Operator: TransMedics
• Contact Address: 200 Minuteman Road, Suite 302 ; Andover MA 01810 US
• Official Correspondent:
  • Thalia Charles
  • 1-978-2697900-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 200 MINUTEMAN RD STE 302 ; Andover, MA 01810 US
• Establishment Type:
  • Manufacture Device in the United States for Export Only
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN P160013 | QBA TRANSMEDICS, INC. [TransMedics]	OCS Lung System	2018-06-05
PMN P160013 | PHO TRANSMEDICS, INC. [TransMedics]	OCS Lung System	2018-06-05
MSB TRANSMEDICS, INC. [TransMedics]	TransMedics Organ Care System	2013-11-07
MSB TRANSMEDICS, INC. [TransMedics]	TransMedics Organ Care System Lung Console	2013-11-07
MSB TRANSMEDICS, INC. [TransMedics]	TransMedics Organ Care System Heart Console	2013-11-07
MSB TRANSMEDICS, INC. [TransMedics]	TransMedics Lung Solution Set	2013-11-07
MSB TRANSMEDICS, INC. [TransMedics]	TransMedics Lung Perfusion Set, including the TransMedics Lung Perfusion Module	2013-11-07
MSB TRANSMEDICS, INC. [TransMedics]	TransMedics Heart Solution Set	2013-11-07
MSB TRANSMEDICS, INC. [TransMedics]	TransMedics Heart Perfusion Set, including the TransMedics Heart Perfusion Module	2013-11-07

Similar & Related FDA Registered Companies

• TransMedics, Inc.
• 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
• 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
• 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