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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 109 Results
productcode NIK PMA Number p Decision Date From 1/1/2016 Decision Date To 1/1/2017
 
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PMA
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ACUITY X4 lead family shelf life Boston Scientific Corp. P010012 S437 12/21/2016
ACUITY X4 Lead Models 4671, 4672, 4674, 4675, 4677... Boston Scientific Corp. P010012 S440 12/19/2016
AMPLIA MRI CRT-D & QUAD CRT-D; BRAVA CRT-D & QUAD ... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S574 12/19/2016
CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE C... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S571 12/14/2016
AUTOGEN X4 CRT-D MODEL G166, G168 and AUTOGEN CRT-... Boston Scientific Corp. P010012 S424 12/12/2016
Claria MRI CRT-D QUAD SureScan; Amplia MRI Quad CR... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S568 11/23/2016
Brava CRT-D; Brava Quad CRT-D; Concerto ICD,II CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S560 11/17/2016
PROMOTE, UNIFY, UNIFY ASSURA, UNIFY QUADRA, QUADRA... Abbott Medical P030054 S313 11/17/2016
QuickFlex and Quartet Leads Abbott Medical P030054 S312 11/06/2016
Brava,Brava Quad CRT-D; Viva S, XT,Viva Quad S, XT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S566 11/02/2016
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