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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 75 Results
productcode NIK PMA Number p Decision Date From 1/1/2020 Decision Date To 1/1/2021
 
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(CRT-D Resynchronization Devices) COGNIS, ENERGEN,... Boston Scientific Corp. P010012 S518 06/15/2020
ACUITY X4 Boston Scientific Corp. P010012 S520 07/07/2020
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S727 12/18/2020
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S721 11/18/2020
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S719 11/18/2020
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S726 12/15/2020
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S712 08/24/2020
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S716 09/30/2020
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S725 12/16/2020
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S710 08/03/2020
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