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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 109 Results
productcode NIK PMA Number p Decision Date From 1/1/2016 Decision Date To 1/1/2017
 
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PMA
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ALLURE AND ALLURE QUADRA FAMILY OF CRT-P DEVICES Abbott Medical P030035 S144 01/04/2016
BRAVA, BRAVA QUAD, CONCERTO, CONCERTO II, CONSULTA... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S521 01/13/2016
AMPLIA MRI/AMPLIA MRI QUAD CRT-D SURESCAN; COMPIA ... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S513 02/01/2016
COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN,... Boston Scientific Corp. P010012 S408 02/05/2016
BRAVA, BRAVA QUAD, CONCERTO II, CONSULTA, MAXIMO I... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S522 02/05/2016
PROMOTE+UNIFY, UNIFY QUADRA, UNIFY ASSURA AND QUAD... Abbott Medical P030054 S297 02/08/2016
FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS Abbott Medical P030035 S138 02/12/2016
QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS Abbott Medical P030054 S291 02/12/2016
SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS St. Jude Medical, Inc. P880006 S094 02/12/2016
MICRONY FAMILY OF PACEMAKERS Abbott Medical P970013 S066 02/12/2016
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