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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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21 to 30 of 62 Results
productcode NIK PMA Number p Decision Date From 1/1/2022 Decision Date To 1/1/2023
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Device
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PMA
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ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-... Boston Scientific Corp. P010012 S563 10/14/2022
Contak CD, Easytrak, Livian, Cognis and Acuity Spi... Boston Scientific Corp. P010012 S564 11/02/2022
MOMENTUM™ CRT-D, MOMENTUM, MOMENTUM™ X4 CRT-D, INO... Boston Scientific Corp. P010012 S565 12/14/2022
MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-... Boston Scientific Corp. P010012 S566 12/20/2022
CareLink SmartSync™ Cobalt Crome Application MEDTRONIC CARDIAC RHYTHM DISEA P010031 S762 01/24/2022
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S768 01/31/2022
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S769 01/21/2022
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S770 01/28/2022
Cobalt MRI CRT-D, Cobalt XT MRI CRT-D and Crome MR... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S771 02/22/2022
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S772 02/17/2022
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