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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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41 to 50 of 75 Results
productcode NIK PMA Number p Decision Date From 1/1/2020 Decision Date To 1/1/2021
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Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, and Crome M... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S706 07/21/2020
CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE C... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S705 07/16/2020
Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, and Crome M... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S704 07/08/2020
ACUITY X4 Boston Scientific Corp. P010012 S520 07/07/2020
Promote/+/RF/Q, Promote Accel, Promote Quadra, Uni... Abbott Medical P030054 S374 06/30/2020
Cardiac Resynchronization Therapy-Defibrillator (C... MicroPort CRM USA Inc. P060027 S101 06/24/2020
Quickflex µ, Quartet Abbott Medical P030054 S379 06/18/2020
(CRT-D Resynchronization Devices) COGNIS, ENERGEN,... Boston Scientific Corp. P010012 S518 06/15/2020
Amplia MRI CRTD-D,Amplia MRI Quad CRT-D,Brava CRT-... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S702 06/08/2020
Cobalt XT HF Quad CRT-D MRI SureScan, Cobalt XT HF... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S701 05/27/2020
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