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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 75 Results
productcode NIK PMA Number p Decision Date From 1/1/2020 Decision Date To 1/1/2021
 
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PMA
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Platinium CRT-D and Platinium 4LV CRT-D (Cardiac R... MicroPort CRM USA Inc. P060027 S104 10/20/2020
Platinium CRT-D and Platinium 4LV CRT-D MicroPort CRM USA Inc. P060027 S103 08/10/2020
Platinium CRT-D and Platinium 4LV CRT-D (Cardiac R... MicroPort CRM USA Inc. P060027 S102 03/06/2020
Cardiac Resynchronization Therapy-Defibrillator (C... MicroPort CRM USA Inc. P060027 S101 06/24/2020
Promote+, Unify, Unify Quadra, Unify Assura, Quadr... Abbott Medical P030054 S388 12/15/2020
Cardiac Resynchronization Therapy (CRT) Abbott Medical P030054 S387 11/20/2020
Promote+, Unity, Unity Quadra, Unity Assura, Quadr... Abbott Medical P030054 S386 10/26/2020
Avant HF CRT-D, Neutrino NxT HF CRT-D, Gallant HF ... Abbott Medical P030054 S385 09/23/2020
Quickflex µ, Quartet Abbott Medical P030054 S384 10/16/2020
Quadra Assura, Unify, Unify Assura, Unify Quadra, ... Abbott Medical P030054 S383 08/06/2020
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