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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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productcode PHO PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
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Device
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Applicant
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PMA
Number
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Decision
Date
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XVIVO Perfusion System (XPS)™ with STEEN Solution™... XVIVO Perfusion, Inc. P180014 S006 11/03/2021
Organ Care System (OCS™) Lung System TransMedics, Inc P160013 S008 08/02/2021
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