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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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21 to 30 of 62 Results
productcode NIK PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
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PMA
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Claria MRI/Claria MRI Quad CRT-D SureScan devices MEDTRONIC CARDIAC RHYTHM DISEA P010031 S672 08/23/2019
Unify, Unify Quadra/Assura and Quadra Assura/MP Abbott Medical P030054 S369 08/19/2019
Amplia MRI/Quad, Brava/Quad, Claria MRI/Quad, Comp... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S677 08/06/2019
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S661 08/01/2019
Resonate, Momentum, Vigilant, Autogen, Dynagen, In... Boston Scientific Corp. P010012 S504 07/31/2019
CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE C... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S675 07/26/2019
Amplia, Amplia Quad; Brava, Brava Quad; Claria, Cl... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S676 07/22/2019
Momentum, Resonate, Autogen, and Dynagen (CRT-D) Boston Scientific Corp. P010012 S507 07/18/2019
Amplia MRI and MRI Quad CRT-D, Brava CRT-D and Qua... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S673 07/18/2019
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S671 07/11/2019
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