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U.S. Department of Health and Human Services

Premarket Approval - PMA
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Device Name
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Applicant
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PMA
Number
Sort by PMA Number [0-9]
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Decision
Date
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tdx cyclosporine and metabolites serume assay Abbott Laboratories P890025S010 02/13/1998
architect ausab ABBOTT LABORATORIES INC P050051S019 12/14/2012
trifecta valve Abbott Medical P100029S013 06/29/2012
cardiovascular permanent pacemaker electrode Abbott Medical P960013S069 04/13/2012
cadence family of icds Abbott Medical P910023S221 02/03/2010
quadra assura/unify assura family of crt-ds Abbott Medical P030054S265 05/29/2014
frontier, frontier ii, anthem families of crtp's Abbott Medical P030035S094 04/13/2012
ellipse/fortify assura family os icd's Abbott Medical P910023S346 12/11/2014
quadra assura / unify assura family of crt-d's Abbott Medical P030054S276 12/11/2014
frontier/frontier ii/ anthem family of crt-p's Abbott Medical P030035S127 12/11/2014

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