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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 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
Number
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Decision
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Cardiac Resynchronization Therapy Defibrillator (C... Boston Scientific Corp. P010012 S510 10/29/2019
CRT-D Resynchronization Devices: COGNIS, ENERGEN, ... Boston Scientific Corp. P010012 S508 10/18/2019
Quadra Assura, Unify, Unify Assura and Unify Quadr... Abbott Medical P030054 S371 10/15/2019
Amplia MRI CRT-D, Amplia MRI Quad CRT-D,Brava CRT-... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S680 10/04/2019
Amplia, Claria MRI CRT-D, Amplia, Claria and Compi... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S681 09/27/2019
Origen, Inogen, Dynagen, Autogen, Momentum, Vigila... Boston Scientific Corp. P010012 S509 09/24/2019
Autogen, Dynagen, Inogen, and Origen NG3 CRT-Ds an... Boston Scientific Corp. P010012 S506 09/18/2019
Amplia MRI, MRI Quad, Brava, Brava Quad, Claria MR... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S679 09/13/2019
Quadra Assura, Unify, Unify Assura, and Unify Quad... Abbott Medical P030054 S370 09/04/2019
Consulta, Protecta and Protecta XT CRT-D MEDTRONIC CARDIAC RHYTHM DISEA P010031 S678 08/30/2019
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