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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 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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Evera MRI DF-1 ICD / Evera S DR /VR ICD / Evera XT... MEDTRONIC CARDIAC RHYTHM DISEA P980016 S654 12/21/2017
Emblem, Emblem MRI S-ICDs BOSTON SCIENTIFIC CORPORATION P110042 S098 12/19/2017
Implantable Cardioverter Defibrillator (ICD) Abbott Medical P910023 S388 12/19/2017
Cardiac Resynchronization Therapy Defibrillator (C... Abbott Medical P950022 S109 12/19/2017
Autogen, Dynagen, Energen, Incepta, Inogen, Moment... BOSTON SCIENTIFIC P960040 S412 12/19/2017
Linox Smart, Protego, and Plexa BIOTRONIK, INC. P980023 S083 12/19/2017
Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve... MEDTRONIC CARDIAC RHYTHM DISEA P980016 S652 12/15/2017
Epicardial Patch Lead MEDTRONIC CARDIAC RHYTHM DISEA P900061 S147 12/14/2017
Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD,... MEDTRONIC CARDIAC RHYTHM DISEA P980016 S650 12/14/2017
Transvene CS/SVC Lead MEDTRONIC Inc. P980050 S113 12/14/2017
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