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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 91 Results
productcode NIK PMA Number p Decision Date From 1/1/2018 Decision Date To 1/1/2019
 
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Contak CD, Easytrak, Livian, Cognis and Acuity Spi... Boston Scientific Corp. P010012 S467 01/07/2018
NG3 Family of CRT-Ds (Autogen, Dynagen, Inogen, Or... Boston Scientific Corp. P010012 S473 02/02/2018
DYNAGEN CRT-D AND X4 CRT-D; INOGEN CRT-D AND X4 CR... Boston Scientific Corp. P010012 S474 01/10/2018
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
Cognis, Energen, Punctua, Incepta, Origen, Inogen,... Boston Scientific Corp. P010012 S477 03/26/2018
DYNAGEN X4; INOGEN X4; ORIGEN X4; AUTOGEN X4; MOME... Boston Scientific Corp. P010012 S478 02/08/2018
NG3 Cardiac Resynchronization Therapy Defibrillato... Boston Scientific Corp. P010012 S479 02/21/2018
RSONATE, MOMENTUM and VIGILANT NG4 CRT-DS Boston Scientific Corp. P010012 S480 03/22/2018
Implantable Cardiac Resynchronization Therpy Defib... Boston Scientific Corp. P010012 S481 03/12/2018
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