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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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21 to 30 of 75 Results
productcode NIK PMA Number p Decision Date From 1/1/2020 Decision Date To 1/1/2021
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Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S717 10/22/2020
Platinium CRT-D and Platinium 4LV CRT-D (Cardiac R... MicroPort CRM USA Inc. P060027 S104 10/20/2020
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Claria MR... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S711 10/19/2020
Quickflex µ, Quartet Abbott Medical P030054 S384 10/16/2020
ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-... Boston Scientific Corp. P010012 S523 10/01/2020
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S716 09/30/2020
Brava CRT-D, Brava Quad CRT-D, Viva Quad CRT-D, Vi... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S708 09/29/2020
Avant HF CRT-D, Neutrino NxT HF CRT-D, Gallant HF ... Abbott Medical P030054 S385 09/23/2020
Promote/+/RF/Q, Promote Accel, Promote Quadra, Uni... Abbott Medical P030054 S380 09/22/2020
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S715 09/18/2020
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