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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 58 Results
productcode NIK PMA Number p Decision Date From 1/1/2023 Decision Date To 1/1/2024
 
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Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S811 01/13/2023
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S812 01/26/2023
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S813 02/03/2023
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S814 02/06/2023
Brava, Brava Quad, Concerto II, Consulta, Maximo I... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S809 02/08/2023
Unify ,Unify Assura, Quadra Assura, Quadra Assura ... Abbott Medical P030054 S404 02/10/2023
Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF Abbott Medical P030054 S406 02/10/2023
Quadra Assura, Unify, Unify Assura, Unify Quadra Abbott Medical P030054 S403 02/21/2023
Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI C... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S810 02/23/2023
Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI C... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S815 03/14/2023
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