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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 62 Results
productcode NIK PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
 
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Device
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PMA
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Decision
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Promote/+/RF/Q, Promote Accel, Promote Quadra, Uni... Abbott Medical P030054 S373 12/23/2019
Quadripolar Pacing Abbott Medical P030054 S372 12/20/2019
Brava CRT-D, Brava Quad CRT-D, Viva Quad CRT-D, Vi... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S683 12/16/2019
Amplia MRI, Amplia MRI Quad, Brava, Brava Quad, Cl... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S684 12/10/2019
ACUITY X4 Electrode 2, 3, and (E24) Boston Scientific Corp. P010012 S512 12/06/2019
Origen CRT-D, Origen X4 CRT-D, Momentum, Momentum ... Boston Scientific Corp. P010012 S513 12/04/2019
Platinium 4LV CRT-D MicroPort CRM USA Inc. P060027 S100 12/04/2019
Amplia MRI CRT-D, Amplia/Claria/Compia MRI QUAD CR... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S685 12/03/2019
CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIR... Boston Scientific Corp. P010012 S511 11/15/2019
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CR... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S682 11/01/2019
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