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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 1/1/2019 Decision Date To 1/1/2020
 
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PMA
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PLATINIUM VR 1210; PLATINIUM VR 1240; PLATINIUM DR... MicroPort CRM USA Inc. P060027 S098 03/19/2019
Cardiac Resynchronization Therapy Defibrillator MicroPort CRM USA Inc. P060027 S099 03/05/2019
Platinium 4LV CRT-D MicroPort CRM USA Inc. P060027 S100 12/04/2019
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S650 01/09/2019
Amplia MRI Quad CRT-D SureScan, Compia MRI Quad CR... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S654 04/10/2019
CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE C... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S657 01/10/2019
Consulta CRT-D, Maximo II CRT-D, Protecta XT CRT-D... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S658 03/05/2019
Amplia MRI CRT-D, MRI Quad CRT-D; Brava CRT-D, Qua... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S659 03/26/2019
Amplia MRI CRT-D, Amplia Quad CRT-D; Brava CRT-D, ... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S660 03/21/2019
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S661 08/01/2019
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