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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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21 to 30 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 S829 09/22/2023
Quadra Assura, Unify, Unify Assura and Unify Quadr... Abbott Medical P030054 S411 09/20/2023
Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI C... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S827 09/11/2023
Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI C... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S831 09/08/2023
Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI C... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S832 08/28/2023
QuickFlex µ, Quartet Abbott Medical P030054 S410 08/08/2023
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S830 08/01/2023
ACUITY™ Spiral, Accessory, Slit Suture Sleeve, ACU... Boston Scientific Corp. P010012 S575 07/21/2023
MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-... Boston Scientific Corp. P010012 S574 07/20/2023
Neutrino™ NxT HF, Avant™ HF, Gallant ™ HF, Entrant... Abbott Medical P030054 S409 07/19/2023
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