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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 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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Unify ,Unify Assura, Quadra Assura, Quadra Assura ... Abbott Medical P030054 S404 02/10/2023
QuickFlex µ, Quartet Abbott Medical P030054 S410 08/08/2023
Quadra Assura, Unify, Unify Assura, Unify Quadra, ... Abbott Medical P030054 S415 12/27/2023
Quadra Assura, Unify, Unify Assura, Unify Quadra Abbott Medical P030054 S403 02/21/2023
Quadra Assura, Unify, Unify Assura and Unify Quadr... Abbott Medical P030054 S411 09/20/2023
Promote/+/RF/Q, Promote Accel, Promote Quadra, Uni... Abbott Medical P030054 S405 04/14/2023
NG3 Cardiac Resynchronization Therapy Defibrillato... Boston Scientific Corp. P010012 S568 05/11/2023
Neutrino™ NxT HF, Avant™ HF, Gallant ™ HF, Entrant... Abbott Medical P030054 S409 07/19/2023
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
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