FDA.reportPublic FDA data

TRANSMEDICS, INC.

Matched from indexed company URL: TransMedics, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30031524633003152463TRANSMEDICS, INC.1N2026-01-01200 MINUTEMAN RD STE 302 Andover MA US 01810

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B00912500Organ Care System - OCS Battery9785520900xx@xx.xx
B00926340OCS Heart System - OCS Heart Solution Set978-552-0900xx@xx.xx
B00944670OCS Lung System - OCS Lung Solution9785520900xx@xx.xx
B00950770OCS Liver System - OCS Liver Bile Salts Set978-552-0900xx@xx.xx
B00950840Organ Care System - OCS Battery9785520900xx@xx.xx
B00958753OCS Lung Donor Flush Set - 24069784947494xzhuang@transmedics.com
B00958755OCS Lung Donor Flush Set - 24069784947494xzhuang@transmedics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1639671360137588P200031Organ Care System (OCS™) LiverQQK2021-09-28
1639671996159695P180051Organ Care System (OCS) Heart SystemQIK2021-09-03
1639671454657405P160013Organ Care System (OCS™) Lung SystemQBA2018-03-22
1639671960535566K231362OCS Heart Leukocyte Depleting FilterDTM2023-10-31
1639672009623388K222535OCS Lung Donor Flush SetMSB2022-11-18
1639671423000631K211314OCS Lung SolutionMSB2021-07-29
1639671689164891

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MSB22022-11-18
DTM12023-10-31
QQK 12021-09-28
QIK 12021-09-03
QBA12018-03-22

PMA#

Organ Care System (OCS®) Liver™

2022-09-19

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 Typenor...

Organ Care System™ (OCS) Lung System

2022-05-06

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 Suppleme...

OCS Heart System

2022-04-27

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...

PMN#

GUDID#

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