Organ Care System (OCS) Lung System

FDA Premarket Approval P160013 S007

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

Approval for a software update (software version 3. 1. 3-c).

DeviceOrgan Care System (OCS) Lung System
Generic NameNormothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation
ApplicantTransMedics, Inc
Date Received2020-09-04
Decision Date2020-12-03
PMAP160013
SupplementS007
Advisory CommitteeGastroenterology/Urology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address TransMedics, Inc 200 Minuteman Road suite 302 andover, MA 01810

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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