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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 62 Results
productcode NIK PMA Number p Decision Date From 1/1/2022 Decision Date To 1/1/2023
 
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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
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S773 02/25/2022
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S774 03/23/2022
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S775 04/11/2022
Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI C... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S776 03/24/2022
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