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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 1/1/2019 Decision Date To 1/1/2020
 
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PMA
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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
Quadripolar Pacing Abbott Medical P030054 S372 12/20/2019
Promote/+/RF/Q, Promote Accel, Promote Quadra, Uni... Abbott Medical P030054 S373 12/23/2019
COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN,... Boston Scientific Corp. P010012 S492 02/22/2019
EasyTrak II Lead Family Boston Scientific Corp. P010012 S493 01/10/2019
Acuity X4 Leads, Acuity Spiral Leads Boston Scientific Corp. P010012 S494 02/28/2019
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