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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 6 of 6 Results
productcode LOZ PMA Number p Decision Date From 1/1/2023 Decision Date To 1/1/2024
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Device
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PMA
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SynCardia temporary Total Artificial Heart (TAH-t)... SYNCARDIA SYSTEMS, LLC P030011 S088 11/01/2023
SynCardia temporary Total Artificial Heart (TAH-t)... SYNCARDIA SYSTEMS, LLC P030011 S087 10/18/2023
SynCardia temporary Total Artificial Heart (TAH-t)... SYNCARDIA SYSTEMS, LLC P030011 S086 08/09/2023
SynCardia temporary Total Artificial Heart (TAH-t)... SYNCARDIA SYSTEMS, LLC P030011 S085 08/01/2023
SynCardia temporary Total Artificial Heart (TAH-t)... SYNCARDIA SYSTEMS, LLC P030011 S064 07/06/2023
SynCardia temporary Total Artificial Heart (TAH-t)... SYNCARDIA SYSTEMS, LLC P030011 S084 04/12/2023
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