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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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31 to 40 of 163 Results
productcode LWS PMA Number p Decision Date From 1/1/2017 Decision Date To 1/1/2018
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Device
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PMA
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Fortify, Fortify Assura, Quadra Assura, Ellipse Abbott Medical P910023 S395 11/08/2017
EMBLEM S-ICD BOSTON SCIENTIFIC CORPORATION P110042 S094 10/27/2017
PLATINIUM VR 1210, 1240; DR 1510, 1540, CRT-D 1711... MicroPort CRM USA Inc. P060027 S088 10/26/2017
Autogen, Dynagen, Inogen,Origen / NG3 Implantable ... BOSTON SCIENTIFIC P960040 S407 10/26/2017
Evera MRI DF ICD /MRI ICD / S DR / S VR / XT DR /X... MEDTRONIC CARDIAC RHYTHM DISEA P980016 S645 10/26/2017
En Trust ICD, Intrinsic ICD, Marquis DR & VR ICD, ... MEDTRONIC CARDIAC RHYTHM DISEA P980016 S639 10/25/2017
Current, Current Accel, Current+, Ellipse, Fortify... Abbott Medical P910023 S381 10/20/2017
Current, Current Accel, Current+, Ellipse, Fortify... Abbott Medical P910023 S382 10/20/2017
Evera MRI ICD/Evera S DR/VR ICD/Evera XT DR/VR ICD... MEDTRONIC CARDIAC RHYTHM DISEA P980016 S643 10/20/2017
Evera MRI ICD/Evera S DR/VR ICD/Evera XT DR/VR ICD... MEDTRONIC CARDIAC RHYTHM DISEA P980016 S644 10/20/2017
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