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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 8 of 8 Results
productcode LOZ PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
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PMA
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SynCardia temporary Total Artificial Heart (TAH-t)... SYNCARDIA SYSTEMS, LLC P030011 S074 11/26/2019
SynCardia temporary Total Artificial Heart (Tah-t)... SYNCARDIA SYSTEMS, LLC P030011 S072 09/19/2019
SynCardia temporary Total Artificial Heart (TAH-t)... SYNCARDIA SYSTEMS, LLC P030011 S073 08/15/2019
SynCardia temporary Total Artificial Heart (TAH-t)... SYNCARDIA SYSTEMS, LLC P030011 S071 07/18/2019
SynCardia temporary Total Artificial Heart (TAH-t)... SYNCARDIA SYSTEMS, LLC P030011 S069 06/26/2019
SynCardia temporary Total Artificial Heart (TAH-t)... SYNCARDIA SYSTEMS, LLC P030011 S068 04/17/2019
SynCardia temporary Total Artifical Heart (TAH-t) ... SYNCARDIA SYSTEMS, LLC P030011 S067 02/20/2019
Syncardia Temporary Total Artificial Heart (TAH-T)... SYNCARDIA SYSTEMS, LLC P030011 S066 01/09/2019
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