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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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41 to 50 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 S814 02/06/2023
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 S812 01/26/2023
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S811 01/13/2023
Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI C... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S810 02/23/2023
Brava, Brava Quad, Concerto II, Consulta, Maximo I... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S809 02/08/2023
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
MOMENTUM™ CRT-D, MOMENTUM, MOMENTUM™ X4 CRT-D, INO... Boston Scientific Corp. P010012 S576 10/18/2023
ACUITY™ Spiral, Accessory, Slit Suture Sleeve, ACU... Boston Scientific Corp. P010012 S575 07/21/2023
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