PMA P160013S001

Device

Organ Care System (OCS™) Lung System

Applicant

TransMedics, Inc.

PMA number

P160013

Supplement

S001

Product code

QBA

Decision date

2018-06-14

Classification

Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

Generic name

Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation

Approval order statement

Approval for protocol for post-approval study (PAS) protocol.

Summary

<a href="#main" target="_new">Quick Links: Skip to main page content</a> <a href="#search_form" target="_new">Skip to Search</a> <a href="#fda-topmenu-home" target="_new">Skip to Topics Menu</a> <a href="#footer" target="_new">Skip to Common Links</a> <a href="#" target="_new"><img src="/scripts/includes/images/img_fdagov_font_adj_small.png" alt="Decrease font size" title="Decrease font size"/></a> <a href="#" target="_new"><img src="/scripts/includes/images/img_fdagov_font_adj_medium.png" alt="Return font size to normal" title="Return font size to normal"/></a> <a href="#" target="_new"><img src="/scripts/includes/images/img_fdagov_font_adj_large.png" alt="Increase font size" title="Increase font size"/></a> <a href="http://www.hhs.gov/" target="_new"><img id="rrimg1" border="0" src="/scripts/includes/images/img_fdagov_hhs_masthead_logo_r.png" alt="U.S. Department of Health and Human Services" title="U.S. Department of Health and Human Services"/></a> <a href="https://www.fda.gov/" target="_new"><img src="/scripts/includes/images/gov-fda-new-white.png" alt="FDA, U.S. Food and Drug Administration" border="0" title="FDA, U.S. Food and Drug Administration"/></a> <a href="https://www.fda.gov/news-events/interactive-media" target="_new">Follow FDA</a> <a href="https://www.fda.gov/about-fda/fda-en-espanol" target="_new">En Espa&ntilde;ol</a> <a href="javascript:document.getElementById('search_form').submit();" target="_new"><img src="/scripts/includes/images/img_fdagov_mast_search_button.png" alt="Search" title="Search this site"/></a> <a href="https://www.fda.gov/" target="_new"><span>Home</span></a> <a href="https://www.fda.gov/food" target="_new"><span>Food</span></a> <a href="https://www.fda.gov/Drugs" target="_new"><span>Drugs</span></a> <a href="https://www.fda.gov/Medical-Devices" target="_new"><span>Medical Devices</span></a> <a href="https://www.fda.gov/radiation-emitting-products" target="_new"><span>Radiation-Emitting Products</span></a> <a href="https://www.fda.gov/vaccines-blood-biologics" target="_new"><span>Vaccines, Blood &amp; Biologics</span></a> <a href="https://www.fda.gov/animal-veterinary" target="_new"><span>Animal &amp; Veterinary</span></a> <a href="https://www.fda.gov/cosmetics" target="_new"><span>Cosmetics</span></a> <a href="https://www.fda.gov/tobacco-products" target="_new"><span>Tobacco Products</span></a> <a href="javascript:window.print();" target="_new"><img src="/scripts/includes/images/img_fdagov_utility_icon_print.png" alt="Print" title="Print this page"/></a> <a href="http://www.addthis.com/bookmark.php?u508=true&v=152&amp;username=fdamain" target="_new"><img src="/scripts/includes/images/img_fdagov_utility_icon_share.png" alt="Share" title="Share this page"/></a> <a href="http://www.addthis.com/bookmark.php" target="_new"><img src="/scripts/includes/images/img_fdagov_utility_icon_email.png" alt="E-mail" title="E-mail this page"/></a> <a href="https://www.fda.gov/" target="_new">FDA Home</a> <a href="http://www.fda.gov/MedicalDevices/default.htm" target="_new">Medical Devices</a> <a href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/default.htm" target="_new">Databases</a> <a href="/scripts/cdrh/devicesatfda/index.cfm" target="_new"><img src="../images/supersearch.gif" align="left" border="0" alt="Super Search Devices@FDA"></a>