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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 of 67 Results
productcode NIK PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
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PMA
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Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S759 10/14/2021
Resonate, Momentum, Vigilant, Autogen, Dynagen, In... Boston Scientific Corp. P010012 S528 10/07/2021
Resonate family of CRT-D's Boston Scientific Corp. P010012 S540 10/07/2021
Contak CD, EasyTrak, Livian, Cognis, and Acuity Sp... Boston Scientific Corp. P010012 S546 10/06/2021
CareLink SmartSync Cobalt, Crome App MEDTRONIC CARDIAC RHYTHM DISEA P010031 S750 09/29/2021
CONTAK CD, CONTAK RENEWAL, LIVIAN, COGNIS, ENERGEN... Boston Scientific Corp. P010012 S542 09/24/2021
EZTRK 2, ACUITY SPIRAL, ORIGEN CRT-D, INOGEN CRT-D... Boston Scientific Corp. P010012 S545 09/24/2021
Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI C... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S758 09/24/2021
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CR... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S757 09/23/2021
ICD ORIGEN CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CR... Boston Scientific Corp. P010012 S544 09/20/2021
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