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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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ORIGEN™ CRT-D, ORIGEN™ X4 CRT-D, MOMENTUM™ CRT-D, ... Boston Scientific Corp. P010012 S549 12/21/2021
Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI C... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S767 12/21/2021
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S765 12/17/2021
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S766 12/09/2021
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S764 12/07/2021
COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN,... Boston Scientific Corp. P010012 S543 11/30/2021
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S763 11/30/2021
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S761 11/18/2021
Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI C... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S760 11/03/2021
ORIGEN CRT-D; ORIGEN X4 CRT-D; INOGEN CRT-D; INOGE... Boston Scientific Corp. P010012 S547 10/21/2021
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