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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 25 of 92 Results
Decision Date From 03/10/2016 Decision Date To 03/21/2016
 
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INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY... BOSTON SCIENTIFIC CORPORATION P140028 S008 03/21/2016
MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AN... MEDTRONIC Inc. P980035 S456 03/21/2016
BIOFINITY (COMFILCON A) CooperVision, Inc. P080011 S041 03/21/2016
MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM MEDTRONIC Inc. P010015 S293 03/21/2016
NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT Novocure GmbH P100034 S016 03/18/2016
VNS THERAPY SYSTEM LivaNova USA, Inc. P970003 S191 03/18/2016
EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM BOSTON SCIENTIFIC CORPORATION P090003 S039 03/18/2016
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONO... Boston Scientific Corp. P130030 S021 03/18/2016
ESTEEM ENVOY MEDICAL CORPORATION P090018 S030 03/18/2016
EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR EBI, LLC P850035 S042 03/18/2016
WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) DEVI... Boston Scientific Corp. P130013 S004 03/18/2016
CAPSUREFIX NOVUS, LEAD AND CAPSUREFIX , NOVUS MRI ... Medtronic, Inc. P930039 S123 03/18/2016
CAPSUREFIX MRI SURE AND SCAN LEAD Medtronic, Inc P090013 S164 03/18/2016
ALGOVITA SPINAL CORD STIMULATION SYSTEM Nuvectra Corporation P130028 S003 03/18/2016
PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM Boston Scientific Corp. P030017 S247 03/18/2016
AMPLATZER MUSCULAR VSD OCCLUDER Abbott Medical P040040 S026 03/18/2016
I-FACTOR PEPTIDE ENHANCED BONE GRAFT CERAPEDICS, LLC P140019 S002 03/18/2016
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCE... EDWARDS LIFESCIENCES, LLC. P100041 S068 03/18/2016
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCES... EDWARDS LIFESCIENCES LLC. P110021 S055 03/18/2016
BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOU... Boston Scientific Corp. P060006 S072 03/18/2016
EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL B... EDWARDS LIFESCIENCES, LLC. P860057 S144 03/18/2016
EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND AC... EDWARDS LIFESCIENCES, LLC. P130009 S050 03/18/2016
SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES EDWARDS LIFESCIENCES, LLC. P140031 S009 03/18/2016
PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING P... Boston Scientific Corp. P110010 S120 03/18/2016
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORON... BOSTON SCIENTIFIC CORPORATION P150003 S007 03/18/2016
 
 
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