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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 54 Results
productcode NIK PMA Number p Decision Date From 1/1/2013 Decision Date To 1/1/2014
 
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PMA
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VIVA XT CRT-D, VIVA S CRT-D, BRAVA CRT-D, VIVA/BRA... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S318 01/29/2013
UNIFY, UNIFY ASSURA, QUADRA ASSURA FAMILY OF CRT-D... Abbott Medical P030054 S250 06/12/2013
UNIFY AND UNIFY QUANDRA FAMILY OF CRT-DS Abbott Medical P030054 S248 06/12/2013
UNIFY AND UNIFY QUADRA CRT-D'S Abbott Medical P030054 S253 11/26/2013
SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS St. Jude Medical, Inc. P880006 S084 06/06/2013
REGENCY, SENSLOG AND DIALOG St. Jude Medical, Inc. P880006 S086 05/14/2013
QUADRIPOLAR PACING PAS (QUAD PAS) Abbott Medical P030054 S236 02/15/2013
QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS Abbott Medical P030054 S238 06/06/2013
PROMOTE, PROMOTE+. PROMOTE RF, PROMOTE ACCEL, UNIF... Abbott Medical P030054 S244 04/11/2013
PROMOTE, PROMOTE ACCEL,PROMOTE Q, PROMOTE QUADRA,P... Abbott Medical P030054 S255 12/17/2013
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