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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 67 Results
productcode NIK PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
 
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Smart Monitor, Smart Spot, SmartView Monitor, Smar... MicroPort CRM USA Inc. P060027 S105 08/13/2021
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S724 02/09/2021
Amplia MRI Quad CRT-D, Claria MRI Quad CRT-D, Coba... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S728 04/01/2021
Cobalt MRI CRT-D, Cobalt XT MRI CRT-D and Crome MR... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S729 02/03/2021
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S730 04/16/2021
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S731 03/04/2021
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S732 03/03/2021
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S733 03/08/2021
Cobaly MRI, XT MRI RT-D and Crome MRI CRT-D MEDTRONIC CARDIAC RHYTHM DISEA P010031 S734 03/25/2021
Amplia MRl CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S735 03/03/2021
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