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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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31 to 40 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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CRT-D Resynchronization Devices: COGNIS, ENERGEN, ... Boston Scientific Corp. P010012 S498 07/08/2019
COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN,... Boston Scientific Corp. P010012 S502 07/08/2019
Amplia MRI CRT-D, Amplia MRI Quard CRt-P, Brava CR... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S670 06/26/2019
NG3 and NG4 Cardiac Resynchronization Therapy Defi... Boston Scientific Corp. P010012 S505 06/21/2019
CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE C... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S669 06/21/2019
Viva, Brava, Protecta, XT, Concerto, Concerto II, ... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S662 06/11/2019
CRT-D Resynchronization Devices COGNIS, ENERGEN, P... Boston Scientific Corp. P010012 S501 06/10/2019
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brav CRT-... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S668 06/05/2019
Amplia MRI CRT-D SureScan, Amplia MRI Quad CRT-D S... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S667 05/30/2019
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S666 05/20/2019
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