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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 of 163 Results
productcode LWS PMA Number p Decision Date From 1/1/2017 Decision Date To 1/1/2018
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PMA
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Emblem BOSTON SCIENTIFIC CORPORATION P110042 S092 12/13/2017
Latitude NXT Patient Management System, Wave Commu... BOSTON SCIENTIFIC P910077 S162 12/13/2017
Teligen, Energen, Punctua, Incepta, Origen, Inogen... BOSTON SCIENTIFIC P960040 S406 12/13/2017
Evera MRI ICD,Evera S DR ICD,Evera MRI DF-1 ICD,Ev... MEDTRONIC CARDIAC RHYTHM DISEA P980016 S651 12/13/2017
Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR ICD;... MEDTRONIC CARDIAC RHYTHM DISEA P980016 S648 12/12/2017
Fortify; Fortify Assura Abbott Medical P910023 S398 12/11/2017
NG3 Implantable Cardiac Defibrillators (ICDs): AUT... BOSTON SCIENTIFIC P960040 S410 12/11/2017
Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD,... MEDTRONIC CARDIAC RHYTHM DISEA P980016 S647 12/11/2017
Fortify Assura , Ellipse Abbott Medical P910023 S397 12/07/2017
EMBLEM SICD GEN 2, SICD EMBLEM MRI , Subcutaneous ... BOSTON SCIENTIFIC CORPORATION P110042 S097 12/06/2017
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