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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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31 to 40 of 91 Results
productcode NIK PMA Number p Decision Date From 1/1/2018 Decision Date To 1/1/2019
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PMA
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Promote+; Unify; Unify Quadra; Unify Assura; Quadr... Abbott Medical P030054 S358 08/14/2018
Protecta CRT-D, Protecta XT CRT-D MEDTRONIC CARDIAC RHYTHM DISEA P010031 S637 08/10/2018
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S639 08/10/2018
ACUITYX4 Lead Straight, ACUITY X4 Lead Spiral S, A... Boston Scientific Corp. P010012 S484 07/27/2018
Easytrak 2, Easytrack 3, Acuity Sprial, Acuity X4 Boston Scientific Corp. P010012 S488 07/26/2018
Amplia MRI CRT-D / Quad CRT-D; Brava CRT-D /Quad C... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S636 07/23/2018
QuickFlex u and Quartet Abbott Medical P030054 S357 07/19/2018
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Claria MR... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S638 07/13/2018
Amplia MRI and Amplia MRI Quad CRT-D SureScan, Com... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S626 06/28/2018
Brava Quad CRT-D, Viva Quad S/XT CRT-D MEDTRONIC CARDIAC RHYTHM DISEA P010031 S635 06/22/2018
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