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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 of 91 Results
productcode NIK PMA Number p Decision Date From 1/1/2018 Decision Date To 1/1/2019
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Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S651 11/13/2018
QuickFlex u, Quartet Abbott Medical P030054 S361 11/07/2018
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S645 11/06/2018
Promote+, Unify, Unify Quadra, Unify Assura, Quadr... Abbott Medical P030054 S363 11/05/2018
Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S648 10/31/2018
Left Heart Leads (QuickFlex u and Quartet) Abbott Medical P030054 S362 10/31/2018
Amplia MRI CRT-D, Quad CRT -D; Brava CRT-D, Quad ... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S647 10/26/2018
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S649 10/24/2018
Unify, Unify Quadra, Unify Assura, Quadra Assura, ... Abbott Medical P030054 S360 10/24/2018
Viva, Brava, Protecta, Protecta XT, COncerto, Conc... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S644 10/18/2018
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