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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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51 to 60 of 62 Results
productcode NIK PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
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Device
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PMA
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Origen, Inogen, Dynagen, Autogen, Momentum, Vigila... Boston Scientific Corp. P010012 S509 09/24/2019
Cardiac Resynchronization Therapy Defibrillator (C... Boston Scientific Corp. P010012 S510 10/29/2019
CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIR... Boston Scientific Corp. P010012 S511 11/15/2019
ACUITY X4 Electrode 2, 3, and (E24) Boston Scientific Corp. P010012 S512 12/06/2019
Origen CRT-D, Origen X4 CRT-D, Momentum, Momentum ... Boston Scientific Corp. P010012 S513 12/04/2019
Quadra Allure/ Quadra Allure MP Cardiac Resynchron... Abbott Medical P030054 S356 01/03/2019
Promote/+/RF/Q, Promote Accel, Promote Quadra, Uni... Abbott Medical P030054 S364 03/13/2019
Unify, Unify Quadra/Assura and Quadra Assura/MP Abbott Medical P030054 S369 08/19/2019
Quadra Assura, Unify, Unify Assura, and Unify Quad... Abbott Medical P030054 S370 09/04/2019
Quadra Assura, Unify, Unify Assura and Unify Quadr... Abbott Medical P030054 S371 10/15/2019
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