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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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SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS St. Jude Medical, Inc. P880006 S094 02/12/2016
PLATINIUM CRT-D (MODELS 1711 AND 1741) MicroPort CRM USA Inc. P060027 S079 07/07/2016
PARADYM CRT-D 8750,PARADYM RF CRT-D 9750(ZL101),PA... MicroPort CRM USA Inc. P060027 S080 05/11/2016
PLATINIUM CRT-D 1711/1741 MicroPort CRM USA Inc. P060027 S081 08/09/2016
Platinium CRT-D 1711; Platinium CRT-D 1741 MicroPort CRM USA Inc. P060027 S082 08/08/2016
Platinum CARDIAC RESYNCHRONIZATION THERAPY DEFBRIL... MicroPort CRM USA Inc. P060027 S084 09/07/2016
Paradym CRT-D; Paradym RF CRT-D (ZL101),(ZL102); I... MicroPort CRM USA Inc. P060027 S085 09/20/2016
Platinium CRT-D 1711, 1741. MicroPort CRM USA Inc. P060027 S086 09/07/2016
CRT-Ds (Cardiac Resynchronization Therapy Defibril... MicroPort CRM USA Inc. P060027 S087 09/21/2016
AMPLIA MRI/AMPLIA MRI QUAD CRT-D SURESCAN; COMPIA ... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S513 02/01/2016
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