Organ Care System™ (OCS) Lung System

FDA Premarket Approval P160013 S009

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceOrgan Care System™ (OCS) Lung System
Generic NameNormothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation
ApplicantTransMedics, 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
Date Received2022-02-07
Decision Date2022-05-06
PMAP160013
SupplementS009
Advisory CommitteeGastroenterology/Urology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductNo
Applicant AddressTransMedics, Inc
200 Minuteman Road
suite 302
andover, 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 Combination ProductNo Approval Order Statement  
Approval For The Addition Of The Lung Small Trachea Cannula Set To The Currently Available Trachea Cannulas For The OCS Lung System.

Supplemental Filings

Supplement NumberDateSupplement Type
P160013Original Filing
S009 2022-02-07 Real-time Process
S008 2021-05-04 Real-time Process
S007 2020-09-04 Real-time Process
S006 2019-09-23 Real-time Process
S005 2019-09-23 Real-time Process
S004
S003 2018-09-27 Real-time Process
S002
S001 2018-04-06 Normal 180 Day Track No User Fee

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