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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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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
Cardiac Resynchronization Therapy Defibrillators (... Boston Scientific Corp. P010012 S495 01/23/2019
ACUITY X4 E24 Molding NOR Optimization Boston Scientific Corp. P010012 S496 02/04/2019
NG4 Devices Boston Scientific Corp. P010012 S497 02/13/2019
CRT-D Resynchronization Devices: COGNIS, ENERGEN, ... Boston Scientific Corp. P010012 S498 07/08/2019
Cardiac Resynchronization Therapy Defibrillator Boston Scientific Corp. P010012 S499 03/13/2019
ACUITY X4 Straight 86CM ,95CM, ACUITY X4 Spiral S ... Boston Scientific Corp. P010012 S500 04/08/2019
CRT-D Resynchronization Devices COGNIS, ENERGEN, P... Boston Scientific Corp. P010012 S501 06/10/2019
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