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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 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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Fourier-Transform Infrared Spectroscopy (FTIR) Boston Scientific Corp. P010012 S578 11/28/2023
MOMENTUM™ CRT-D, MOMENTUM, MOMENTUM™ X4 CRT-D, INO... Boston Scientific Corp. P010012 S577 11/21/2023
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S836 11/20/2023
HeartLogic™ Boston Scientific Corp. P010012 S571 11/15/2023
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Claria MR... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S834 11/03/2023
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S835 11/02/2023
Avant, Neutrino NxT, Gallant, Entrant, Unify, Unif... Abbott Medical P030054 S413 10/31/2023
Multicenter Automatic Defibrillator Implantation T... Boston Scientific Corp. P010012 S570 10/19/2023
MOMENTUM™ CRT-D, MOMENTUM, MOMENTUM™ X4 CRT-D, INO... Boston Scientific Corp. P010012 S576 10/18/2023
Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI C... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S833 09/29/2023
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