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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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31 to 40 of 67 Results
productcode NIK PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
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PMA
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CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIR... Boston Scientific Corp. P010012 S541 07/23/2021
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Claria MR... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S752 07/22/2021
Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI C... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S751 07/14/2021
Promote+, Unify, Unify Quadra, Unify Assura, Quadr... Abbott Medical P030054 S393 07/07/2021
Brava CRT-D, Brava Quad CRT-D, Viva Quad S CRT-D, ... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S749 07/02/2021
Cobalt XT HF Quad CRT-D MRI SureScan, Coblat HF Qu... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S742 06/29/2021
Promote/+/RF/Q, Promote Accel, Promote Quadra, Uni... Abbott Medical P030054 S392 06/28/2021
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S746 06/16/2021
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S748 06/04/2021
CareLink SmartSync Viva Consulta Syncra Advisa Ens... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S737 05/27/2021
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