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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 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 S721 11/18/2020
Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, and Crome M... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S722 11/18/2020
CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIR... Boston Scientific Corp. P010012 S526 11/12/2020
Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI C... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S718 11/11/2020
ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-... Boston Scientific Corp. P010012 S527 11/05/2020
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S713 11/02/2020
Unify, Unify Quadra, Unify Assura, Quadra Assura, ... Abbott Medical P030054 S382 10/28/2020
Promote+, Unity, Unity Quadra, Unity Assura, Quadr... Abbott Medical P030054 S386 10/26/2020
COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN,... Boston Scientific Corp. P010012 S522 10/22/2020
ICD AUTOGEN CRT-D, ICD DYNAGEN CRT-D, ICD INOGEN C... Boston Scientific Corp. P010012 S524 10/22/2020
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