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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 7 of 7 Results
productcode LOZ PMA Number p Decision Date From 1/1/2015 Decision Date To 1/1/2016
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SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)... SYNCARDIA SYSTEMS, LLC P030011 S036 12/09/2015
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T... SYNCARDIA SYSTEMS, LLC P030011 S032 11/27/2015
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART SYNCARDIA SYSTEMS, LLC P030011 S034 11/02/2015
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)... SYNCARDIA SYSTEMS, LLC P030011 S035 10/29/2015
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)... SYNCARDIA SYSTEMS, LLC P030011 S033 10/22/2015
FREEDOM DRIVER SYSTEM SYNCARDIA SYSTEMS, LLC P030011 S031 07/29/2015
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART SYNCARDIA SYSTEMS, LLC P030011 S030 02/12/2015
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