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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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31 to 40 of 58 Results
productcode NIK PMA Number p Decision Date From 1/1/2023 Decision Date To 1/1/2024
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PMA
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Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S828 07/17/2023
Cardiac Resynchronization Therapy Defibrillators (... Boston Scientific Corp. P010012 S573 07/07/2023
ACUITY™ Spiral, ACUITY™ X4 Straight, ACUITY™ X4 Sp... Boston Scientific Corp. P010012 S572 07/06/2023
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S818 07/05/2023
Avant™ HF, Neutrino™ NxT HF, Gallant™ HF, Entrant™... Abbott Medical P030054 S407 06/15/2023
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S826 06/14/2023
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S823 06/13/2023
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S825 06/09/2023
Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI C... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S822 06/06/2023
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S821 05/17/2023
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