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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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81 to 90 of 91 Results
productcode NIK PMA Number p Decision Date From 1/1/2018 Decision Date To 1/1/2019
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PMA
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Unify Assura, Quadra Assura, Quadra Assura MP Abbott Medical P030054 S345 02/06/2018
NG3 Family of CRT-Ds (Autogen, Dynagen, Inogen, Or... Boston Scientific Corp. P010012 S473 02/02/2018
Promote+, Quadra Assura, Unify, Unify Assura, and ... Abbott Medical P030054 S347 02/01/2018
Brava CRT-D, Brava Quad CRT-D, Viva Quad S CRT-D, ... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S610 01/31/2018
Cardiac Resynchronization Therapy Defibrillator CR... MicroPort CRM USA Inc. P060027 S092 01/25/2018
Origen, Inogen, Dynagen, Autogen, Momentum, Vigila... Boston Scientific Corp. P010012 S475 01/19/2018
Cardiac Resynchronization Therapy Defibrillator Mo... Boston Scientific Corp. P010012 S476 01/15/2018
DYNAGEN CRT-D AND X4 CRT-D; INOGEN CRT-D AND X4 CR... Boston Scientific Corp. P010012 S474 01/10/2018
Contak CD, Easytrak, Livian, Cognis and Acuity Spi... Boston Scientific Corp. P010012 S467 01/07/2018
Slit Suture Sleeve; Vein Pick Abbott Medical P030054 S343 01/05/2018
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