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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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Device
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PMA
Number
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Decision
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Promote/+/RF/Q, Promote Accel, Promote Quadra, Uni... Abbott Medical P030054 S396 01/07/2022
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 S398 05/17/2022
Avant HF, Neutrino NxT HF, Gallant HF, and Entrant... Abbott Medical P030054 S399 07/14/2022
Quickflex µ, Quartet Abbott Medical P030054 S400 08/01/2022
Promote/+/RF/Q, Promote Accel, Promote Quadra, Uni... Abbott Medical P030054 S401 09/30/2022
Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF Abbott Medical P030054 S402 09/09/2022
CRT-D Resynchronization Devices Boston Scientific Corp. P010012 S548 02/24/2022
Contak CD, Easytrak, Livian, Cognis and Acuity Spi... Boston Scientific Corp. P010012 S550 03/04/2022
ACUITY Spiral Coronary Venous Pace/Sense Lead, ACU... Boston Scientific Corp. P010012 S551 03/08/2022
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