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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 1/1/2022 Decision Date To 1/1/2023
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PMA
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RESONATE™ HF, RESONATE™, RESONATE™ X4, MOMENTUM™, ... Boston Scientific Corp. P010012 S552 08/26/2022
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S800 08/25/2022
Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI C... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S798 08/16/2022
Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI C... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S797 08/08/2022
Quickflex µ, Quartet Abbott Medical P030054 S400 08/01/2022
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S795 07/25/2022
Momentum CRT-D, Momentum X4 CRT-D, ICD Inogen CRT-... Boston Scientific Corp. P010012 S556 07/22/2022
CareLink SmartSync Cobalt/Crome App, Cobalt MRI CR... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S791 07/20/2022
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S793 07/19/2022
Avant HF, Neutrino NxT HF, Gallant HF, and Entrant... Abbott Medical P030054 S399 07/14/2022
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