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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 91 Results
productcode NIK PMA Number p Decision Date From 1/1/2018 Decision Date To 1/1/2019
 
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PMA
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quickflex u, quartet cardiac resynchronization the... Abbott Medical P030054 S367 12/17/2018
tendril sts 2088tc lead Abbott Medical P030054 S355 12/13/2018
unify, unify quadra, unify assura, quadra assura, ... Abbott Medical P030054 S365 12/12/2018
crt-ds (cardiac resynchronization therapy defibril... MicroPort CRM USA Inc. P060027 S097 12/06/2018
quickflex u, quartet cardiac resynchronization the... Abbott Medical P030054 S366 12/05/2018
amplia mri crt-d, amplia mri quad crt-d, brava crt... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S656 12/03/2018
amplia mri crt-d amplia mri quad crt-d, brava crt-... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S655 11/28/2018
amplia mri crt-d, quard crt-d; brava crt-d, quard ... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S653 11/19/2018
origen, inogen, dynagen, autogen, momentum, vigila... Boston Scientific Corp. P010012 S491 11/16/2018
amplia mri crt-d, quad crt-d; brava crt-d, quad cr... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S652 11/15/2018
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