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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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21 to 30 of 91 Results
productcode NIK PMA Number p Decision Date From 1/1/2018 Decision Date To 1/1/2019
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Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S646 10/18/2018
CRT-Ds Autogen, Inogen, Dynagen, Origen, Resonate,... Boston Scientific Corp. P010012 S490 10/10/2018
QuickFlex u 1258T LV Lead Abbott Medical P030054 S359 10/09/2018
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Claria MR... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S640 10/03/2018
Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S642 09/05/2018
Protecta CRT-D and Protectea XT CRT-D MEDTRONIC CARDIAC RHYTHM DISEA P010031 S643 09/05/2018
Dynagen CRT-D, Dynagen X4 CRT-D, Inogen CRT-D, Ino... Boston Scientific Corp. P010012 S489 09/04/2018
MANAGE HF Study Boston Scientific Corp. P010012 S486 08/21/2018
Longitudinal Surveillance Registry of the ACUITY S... Boston Scientific Corp. P010012 S487 08/20/2018
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S641 08/16/2018
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