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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 5 of 5 Results
productcode QBA PMA Number p Decision Date From 1/1/2023 Decision Date To 1/1/2024
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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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Organ Care System (OCS™) Lung System TransMedics, Inc P160013 S013 06/28/2023
Organ Care System™ (OCS™) Lung TransMedics, Inc P160013 S014 06/28/2023
Organ Care System (OCS™) Lung System TransMedics, Inc P160013 S012 05/09/2023
Organ Care System (OCS™) Lung System TransMedics, Inc P160013 S010 02/24/2023
Organ Care System (OCS™) Lung TransMedics, Inc P160013 S011 02/23/2023
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