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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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41 to 50 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 ICD/Evera S DR/VR ICD/Evera XT DR/VR ICD... MEDTRONIC CARDIAC RHYTHM DISEA P980016 S642 10/19/2017
Fortify / Fortify Assura / Ellipse Abbott Medical P910023 S394 10/18/2017
Durata and Optisure High Voltage Lead Abbott Medical P950022 S110 10/18/2017
EMBLEM Subcutaneous Implantable Defibrillator (S-I... BOSTON SCIENTIFIC CORPORATION P110042 S093 10/16/2017
Current+ CD1211-36, CD2211-36, CD1211-36Q, CD2211-... Abbott Medical P910023 S393 10/16/2017
Durata and Optisure Family of High Voltage Leads Abbott Medical P950022 S111 10/16/2017
ICDs: PUNCTUA, ENERGEN, INCEPTA BOSTON SCIENTIFIC P960040 S404 10/11/2017
Evera MRI DF ICD, MRI ICD, S DR ICD, S VR ICD, XT ... MEDTRONIC CARDIAC RHYTHM DISEA P980016 S641 10/05/2017
Model 3501 EMBLEM S-ICD subcutaneous Electrode BOSTON SCIENTIFIC CORPORATION P110042 S077 09/29/2017
ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIGILA... BOSTON SCIENTIFIC P960040 S402 09/28/2017
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