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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 4 of 4 Results
productcode PHO PMA Number p Decision Date From 1/1/2020 Decision Date To 1/1/2021
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Device
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PMA
Number
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Decision
Date
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Organ Care System (OCS) Lung System TransMedics, Inc P160013 S007 12/03/2020
XVIVO Perfusion System with STEEN Solution Perfusa... XVIVO Perfusion, Inc. P180014 S005 10/23/2020
XVIVO Perfusion System (XPS) with STEEN Solution P... XVIVO Perfusion, Inc. P180014 S004 04/26/2020
Xvivo Perfusion System (XPS) with Steen Solution P... XVIVO Perfusion, Inc. P180014 S003 04/24/2020
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