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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 142 Results
productcode LWS PMA Number p Decision Date From 1/1/2018 Decision Date To 1/1/2019
 
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Device
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PMA
Number
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Decision
Date
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Durata, Optisure High Voltage Passive, High Voltag... Abbott Medical P950022 S126 12/17/2018
Tendril STS 2088TC Lead Abbott Medical P910023 S410 12/13/2018
Implantable Cardioverter Defibrillatory (Non-CRT) ... BIOTRONIK, INC. P980023 S088 12/13/2018
Cortify, Fortify Assura, and Ellipse Abbott Medical P910023 S415 12/11/2018
Durata and Optisure Abbott Medical P950022 S124 12/11/2018
EMBLEM S-ICD Pulse Generator; EMBLEM MRI S-ICD Pul... BOSTON SCIENTIFIC CORPORATION P110042 S117 12/06/2018
Durata, Optisure High Voltage Active and Passive L... Abbott Medical P950022 S125 12/05/2018
Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR I... MEDTRONIC CARDIAC RHYTHM DISEA P980016 S697 12/03/2018
EMBLEM S-ICD PG Models A209 and A219 BOSTON SCIENTIFIC CORPORATION P110042 S118 11/29/2018
Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR I... MEDTRONIC CARDIAC RHYTHM DISEA P980016 S696 11/28/2018
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