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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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21 to 30 of 109 Results
productcode NIK PMA Number p Decision Date From 1/1/2016 Decision Date To 1/1/2017
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Device
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PMA
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Paradym CRT-D; Paradym RF CRT-D (ZL101),(ZL102); I... MicroPort CRM USA Inc. P060027 S085 09/20/2016
Amplia MRI & Quad CRT-D's; Brava CRT-D & Quad CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S559 09/15/2016
NG3 Cardiac Resynchronization Therapy-Defibrillato... Boston Scientific Corp. P010012 S431 09/13/2016
Amplia MRI/MRI Quad, Brava/Brava Quad, Compia MRI/... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S557 09/12/2016
Amplia MRI SureScan Model DTMB1D4, Amplia MRI Quad... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S540 09/07/2016
Platinum CARDIAC RESYNCHRONIZATION THERAPY DEFBRIL... MicroPort CRM USA Inc. P060027 S084 09/07/2016
Platinium CRT-D 1711, 1741. MicroPort CRM USA Inc. P060027 S086 09/07/2016
Concerto, Right Ventricular Lead Integrity Alert, ... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S554 09/06/2016
UNIFY ASSURA, QUADRA ASSURA Abbott Medical P030054 S307 09/06/2016
ACUITY X4 Drug Collar Component Dwell Time Boston Scientific Corp. P010012 S430 09/01/2016
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