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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 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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Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF Abbott Medical P030054 S402 09/09/2022
Promote/+/RF/Q, Promote Accel, Promote Quadra, Uni... Abbott Medical P030054 S401 09/30/2022
Quickflex µ, Quartet Abbott Medical P030054 S400 08/01/2022
Avant HF, Neutrino NxT HF, Gallant HF, and Entrant... Abbott Medical P030054 S399 07/14/2022
Promote/+/RF/Q, Promote Accel, Promote Quadra, Uni... Abbott Medical P030054 S398 05/17/2022
Avant HF; Neutrino NxT HF; Gallant HF; Neutrino Nx... Abbott Medical P030054 S397 01/13/2022
Promote/+/RF/Q, Promote Accel, Promote Quadra, Uni... Abbott Medical P030054 S396 01/07/2022
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S808 11/22/2022
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S806 10/25/2022
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S805 11/03/2022
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