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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 130 of 130 Results
PMA Number: P860057 Decision Date to 05/02/2016
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carpentier-edwards perimount pericardial aortic bioprosthesi... EDWARDS LIFESCIENCES, LLC. P860057 S139 10/27/2015
carpentier-edwards pericardial aortic bioprosthesis, theon p... EDWARDS LIFESCIENCES, LLC. P860057 S127 10/19/2015
carpentier-edwards perimount pericardial aortic bioprosthesi... EDWARDS LIFESCIENCES, LLC. P860057 S138 08/07/2015
carpentier-edwards perimount pericardial aortic bioprosthesi... EDWARDS LIFESCIENCES, LLC. P860057 S137 06/18/2015
carpentier-edwards perimount aortic & mitral bioprosthesis f... EDWARDS LIFESCIENCES, LLC. P860057 S135 06/11/2015
carpentier-edwards perimount pericardial aortic bioprosthesi... EDWARDS LIFESCIENCES, LLC. P860057 S136 04/23/2015
carpenter-edwards perimount bioprosthesis heart valve fami... EDWARDS LIFESCIENCES, LLC. P860057 S134 04/16/2015
carpentier-edwards perimount pericardial aortic bioprosthesi... EDWARDS LIFESCIENCES, LLC. P860057 S132 02/11/2015
carpentier-edwards perimount pericardial bioprosthesis EDWARDS LIFESCIENCES, LLC. P860057 S131 01/30/2015
carpentier-edwards perimount pericardiial aortic bioprosthes... EDWARDS LIFESCIENCES, LLC. P860057 S130 01/12/2015
carpentier-edwards perimount pericardial aortic biopprosthes... EDWARDS LIFESCIENCES, LLC. P860057 S129 11/14/2014
carpentier-edwards perimount mitra & aortic,theon,rsr,theon ... EDWARDS LIFESCIENCES, LLC. P860057 S128 10/02/2014
carpentier-edwards perimount pericardial aortic bioprosthesi... EDWARDS LIFESCIENCES, LLC. P860057 S126 08/11/2014
carpentier-edwards perimount pericardial bioprostheses EDWARDS LIFESCIENCES, LLC. P860057 S118 08/04/2014
carpentier-edwards perimount pericardial aortic bioprosthesi... EDWARDS LIFESCIENCES, LLC. P860057 S125 06/18/2014
carpentier-edwards perimount pericardial aortic bioprothesis... EDWARDS LIFESCIENCES, LLC. P860057 S121 05/19/2014
carpentier-edwards perimount pericardfial aortic bioprosthes... EDWARDS LIFESCIENCES, LLC. P860057 S124 05/13/2014
carpentier-edwards perimount pericardial bioprostheses EDWARDS LIFESCIENCES, LLC. P860057 S123 05/01/2014
carpentier-edwards perimount magna pericardial aortic biopro... EDWARDS LIFESCIENCES, LLC. P860057 S122 04/30/2014
carpentier-edwards perimount pericardial aortic bioprosthesi... EDWARDS LIFESCIENCES, LLC. P860057 S120 03/27/2014
carpentier-edwards perimount pericardial aortic bioprosthesi... EDWARDS LIFESCIENCES, LLC. P860057 S119 03/14/2014
carpentier-edwards perimount magna mitral pericardial biopro... EDWARDS LIFESCIENCES, LLC. P860057 S116 01/24/2014
carpentier-edwards perimount pericardial aortic bioprothesis... EDWARDS LIFESCIENCES, LLC. P860057 S117 01/23/2014
carpentier-edwards perimount pericardial aortic and mitral b... EDWARDS LIFESCIENCES, LLC. P860057 S115 12/19/2013
carpentier-edwards perimount pericardial aortic bioprosthesi... EDWARDS LIFESCIENCES, LLC. P860057 S114 11/26/2013
carpentier - edeards perimount pericardial aortic bioprosthe... EDWARDS LIFESCIENCES, LLC. P860057 S113 10/11/2013
carpentier-edwards perimount pericardial aortic bioprosthesi... EDWARDS LIFESCIENCES, LLC. P860057 S112 09/23/2013
carpentier edwards perimount pericardial aotric bioprosthesi... EDWARDS LIFESCIENCES, LLC. P860057 S111 09/20/2013
carpentier-edwards perimount magna mitral ease pericardial b... EDWARDS LIFESCIENCES, LLC. P860057 S110 08/16/2013
carpentier-edwards perimount pericardial aortic bioprosthesi... EDWARDS LIFESCIENCES, LLC. P860057 S109 06/25/2013
carpentier-edwards perimount pericardial aortic bioprosthesi... EDWARDS LIFESCIENCES, LLC. P860057 S100 06/11/2013
carpentier-edwards perimount pericardial aortic bioprosthesi... EDWARDS LIFESCIENCES, LLC. P860057 S108 06/10/2013
carpentier-edwards perimount pericardial aortic bioprosthesi... EDWARDS LIFESCIENCES, LLC. P860057 S107 04/24/2013
carpentier-edwards perimount pericardial aortic bioprothesis EDWARDS LIFESCIENCES, LLC. P860057 S106 04/16/2013
carpentier-edwards perimount percardial aortic bioprosthesis... EDWARDS LIFESCIENCES, LLC. P860057 S104 03/12/2013
carpentier-edwards perimount bioprostheses EDWARDS LIFESCIENCES, LLC. P860057 S105 03/12/2013
carpentier-edwards perimount family of pericardial bioprost... EDWARDS LIFESCIENCES, LLC. P860057 S098 02/28/2013
perimount pericardial aortic and mitral bioprosthesis EDWARDS LIFESCIENCES, LLC. P860057 S103 02/14/2013
carpentier-edwards perimount bioprostheses with thermafix ti... EDWARDS LIFESCIENCES, LLC. P860057 S102 01/30/2013
carpentier-edwards perimount pericardial aortic bioprosthesi... EDWARDS LIFESCIENCES, LLC. P860057 S101 01/08/2013
carpentier-edwards perimount pericardial aortic bioprosthesi... EDWARDS LIFESCIENCES, LLC. P860057 S099 12/28/2012
carpentier-edwards perimount pericardial aortic bioprosthesi... EDWARDS LIFESCIENCES, LLC. P860057 S097 12/11/2012
various families of perimount, rsr, theon, rsr pericardial a... EDWARDS LIFESCIENCES, LLC. P860057 S096 12/10/2012
carpentier-edwards perimount pericardial aortic and mitral v... EDWARDS LIFESCIENCES, LLC. P860057 S095 11/26/2012
capentier-edwards perimount theon, theon psr, magna, magna e... EDWARDS LIFESCIENCES, LLC. P860057 S094 11/20/2012
capentier-edwards perimount theon, theon psr, magna, magna e... EDWARDS LIFESCIENCES, LLC. P860057 S093 11/13/2012
carpentier-edwards perimount pericardial bioprosthesis EDWARDS LIFESCIENCES, LLC. P860057 S092 10/04/2012
capentier-edwards perimount pericardial bioprosthesis EDWARDS LIFESCIENCES, LLC. P860057 S091 09/19/2012
carpentier-edwards perimount pericardial aortic bioproshesis EDWARDS LIFESCIENCES, LLC. P860057 S090 07/11/2012
carpentier-edwards perimount pericardial bioprosthesis EDWARDS LIFESCIENCES, LLC. P860057 S089 05/30/2012
carpentier-edwards perimount pericardial bioprosthesis model... EDWARDS LIFESCIENCES, LLC. P860057 S088 05/15/2012
carpentier-edwards perimount pericardial bioprosthesis EDWARDS LIFESCIENCES, LLC. P860057 S087 04/13/2012
carpentier-edwards perimount pericardial bioprosthesis EDWARDS LIFESCIENCES, LLC. P860057 S086 03/22/2012
carpentier-edwards perimount pericardial bioprosthesis model... EDWARDS LIFESCIENCES, LLC. P860057 S085 02/24/2012
carpentier-edwards perimount pericardial bioprostheses EDWARDS LIFESCIENCES, LLC. P860057 S082 01/19/2012
carpentier-edwards perimount pericardial bioprostheses EDWARDS LIFESCIENCES, LLC. P860057 S083 01/18/2012
carpentier-edwards perimount pericardial bioprosthetiv valve... EDWARDS LIFESCIENCES, LLC. P860057 S081 12/12/2011
perimount bioprostheses EDWARDS LIFESCIENCES, LLC. P860057 S079 09/21/2011
carpentier-edwards perimount pericardial bioprosthetic valve... EDWARDS LIFESCIENCES, LLC. P860057 S072 07/27/2011
carpentier-edwards perimount magna mitral pericardial biopro... EDWARDS LIFESCIENCES, LLC. P860057 S071 07/26/2011
carpentier-edwards perimount pericardial/rsr/magna/magna eas... EDWARDS LIFESCIENCES, LLC. P860057 S078 05/05/2011
glutaraldehyde solution system EDWARDS LIFESCIENCES, LLC. P860057 S076 03/03/2011
carpentier-edwards perimount pericardial bioprosthesis EDWARDS LIFESCIENCES, LLC. P860057 S075 01/20/2011
carpentier-edwards perimount pericardial bioprosthesis EDWARDS LIFESCIENCES, LLC. P860057 S074 12/23/2010
carpentier-edwards perimount pericardial bioprosthetic valve... EDWARDS LIFESCIENCES, LLC. P860057 S073 12/22/2010
carpentier-edwards perimount pericardial bioprosthesis EDWARDS LIFESCIENCES, LLC. P860057 S070 10/27/2010
carpentier-edwards perimount pericardial bioprostheses EDWARDS LIFESCIENCES, LLC. P860057 S069 07/09/2010
carpentier-edwards perimount magna mitral ease percardial bi... EDWARDS LIFESCIENCES, LLC. P860057 S068 06/24/2010
carpentier-edwards perimount bioprosthesis heart valve EDWARDS LIFESCIENCES, LLC. P860057 S063 03/25/2010
carpentier-edwards perimount magna mitral pericardial biopro... EDWARDS LIFESCIENCES, LLC. P860057 S065 03/05/2010
carpentier-edwards perimount pericardial bioprothesis models... EDWARDS LIFESCIENCES, LLC. P860057 S067 02/24/2010
carpentier-edwards perimount pericardial bioprostheses model... EDWARDS LIFESCIENCES, LLC. P860057 S066 02/18/2010
carpentier-edwards perimount pericardial bioprosthesis EDWARDS LIFESCIENCES, LLC. P860057 S064 01/12/2010
carpentier-edwards perimount pericardial bioprosthesis model... EDWARDS LIFESCIENCES, LLC. P860057 S062 01/05/2010
carpentier-edwards perimount pericardial bioprostheses heart... EDWARDS LIFESCIENCES, LLC. P860057 S055 12/11/2009
carpentier-edwards perimount pericardial bioprosthesis model... EDWARDS LIFESCIENCES, LLC. P860057 S053 12/08/2009
carpentier-edwards perimount percardial bioprosthesis EDWARDS LIFESCIENCES, LLC. P860057 S061 11/25/2009
carpentier-edwards perimount pericardial bioprostheses EDWARDS LIFESCIENCES, LLC. P860057 S060 11/06/2009
carpentier-edwards perimount magna ease pericardial aortic b... EDWARDS LIFESCIENCES, LLC. P860057 S057 11/03/2009
carpentier-edwards perimount plus pericardial bioprosthesis EDWARDS LIFESCIENCES, LLC. P860057 S059 09/18/2009
carpentier-edwards perimount pericardial bioprosthesis EDWARDS LIFESCIENCES, LLC. P860057 S058 07/21/2009
carpentier-edwards perimount magna mitral ease pericardial b... EDWARDS LIFESCIENCES, LLC. P860057 S056 07/09/2009
capentier edwards perimount magna ease pericardial aortic bi... EDWARDS LIFESCIENCES, LLC. P860057 S042 05/07/2009
carpentier-edwards perimount magna ease mitral bioprostheses... EDWARDS LIFESCIENCES, LLC. P860057 S054 02/20/2009
carpentier-edwards perimount magna mitral bioprosthesis, mod... EDWARDS LIFESCIENCES, LLC. P860057 S051 01/27/2009
carpentier-edwards perimount pericardial bioprosthesis EDWARDS LIFESCIENCES, LLC. P860057 S052 12/17/2008
carpentier-edwards perimount pericardial bioprosthesis EDWARDS LIFESCIENCES, LLC. P860057 S050 10/29/2008
carpentier-edwards perimount magna mitral pericardial biopro... EDWARDS LIFESCIENCES, LLC. P860057 S029 08/29/2008
carpentier-edwards perimount percardial bioprosthesis EDWARDS LIFESCIENCES, LLC. P860057 S048 07/10/2008
carpentier-edwards perimount pericardial bioprosthesis model... EDWARDS LIFESCIENCES, LLC. P860057 S047 07/08/2008
carpentier-edwards perimount pericardial EDWARDS LIFESCIENCES, LLC. P860057 S046 06/06/2008
carpentier-edwards, theon, rsr, theon rsr, magna, plus mitra... EDWARDS LIFESCIENCES, LLC. P860057 S045 05/23/2008
carpentier-edwards perimount pericardial bioprosthesis EDWARDS LIFESCIENCES, LLC. P860057 S044 12/13/2007
carpentier-edwards perimount magna bioprostheses models 3000... EDWARDS LIFESCIENCES, LLC. P860057 S041 02/13/2007
carpentier-edwards perimount pericardial bioprosthesis 3000,... EDWARDS LIFESCIENCES, LLC. P860057 S037 02/08/2007
carpentier-edwards perimount pericardial bioprosthesis EDWARDS LIFESCIENCES, LLC. P860057 S038 01/29/2007
perimount pericardial bioprostheses EDWARDS LIFESCIENCES, LLC. P860057 S039 01/18/2007
perimount, perimount magna and perimount plus percardial bio... EDWARDS LIFESCIENCES, LLC. P860057 S036 01/08/2007
carpentier-edwards perimount pericardial aortic bioprosthesi... EDWARDS LIFESCIENCES, LLC. P860057 S040 11/08/2006
carpentier-edwards perimount pericardial bioprosthesis model... EDWARDS LIFESCIENCES, LLC. P860057 S035 07/18/2006
carpentier-edwards perimount plus mitral pericardial biopros... EDWARDS LIFESCIENCES, LLC. P860057 S033 05/18/2006
carpentier edwards perimount pericardial bioprosthesis EDWARDS LIFESCIENCES, LLC. P860057 S034 05/12/2006
carpentier-edwards perimount pericardial bioporsthesis model... EDWARDS LIFESCIENCES, LLC. P860057 S032 03/24/2006
carpentier-edwards perimount pericardial bioprosthesis EDWARDS LIFESCIENCES, LLC. P860057 S031 12/06/2005
carpentier-edwards perimount pericardial bioprosthesis, mode... EDWARDS LIFESCIENCES, LLC. P860057 S030 10/07/2005
carpentier-edwards perimount pericardial bioprosthesis, mode... EDWARDS LIFESCIENCES, LLC. P860057 S028 05/20/2005
carpentier-edwards perimount pericardial bioprosthesis model... EDWARDS LIFESCIENCES, LLC. P860057 S027 04/08/2005
carpentier-edwards perimount pericardial bioprosthesis model... EDWARDS LIFESCIENCES, LLC. P860057 S023 04/07/2005
carpentier-edwards perimount pericardial bioprosthesis model... EDWARDS LIFESCIENCES, LLC. P860057 S026 02/28/2005
perimount pericardial bioprosthesis models 2700,2700tfx,2800... EDWARDS LIFESCIENCES, LLC. P860057 S025 01/19/2005
carpentier-edwards perimount pericardial bioprothesis, model... EDWARDS LIFESCIENCES, LLC. P860057 S024 12/29/2004
perimount pericardial bioprosthesis, models 2700, 2800 (peri... EDWARDS LIFESCIENCES, LLC. P860057 S022 01/26/2004
carpentier-edwards perimount magna pericardial bioprosthesis... EDWARDS LIFESCIENCES, LLC. P860057 S018 11/14/2003
carpentier-edwards perimount pericardial bioprosthesis EDWARDS LIFESCIENCES, LLC. P860057 S019 05/09/2003
perimount plus pericardial bioprosthesis,model 6900p,mitral EDWARDS LIFESCIENCES, LLC. P860057 S021 04/18/2003
carpentier-edwards perimount pericardial bioprosthesis EDWARDS LIFESCIENCES, LLC. P860057 S020 12/31/2002
carpentier-edwards perimount pericardial bioprosthesis EDWARDS LIFESCIENCES, LLC. P860057 S016 11/29/2001
carpentier-edwards perimount pericardial bioprosthesis model... EDWARDS LIFESCIENCES, LLC. P860057 S015 05/15/2001
carpentier-edwards perimount pericardial bioprosthesis EDWARDS LIFESCIENCES, LLC. P860057 S017 05/15/2001
carpentier-edwards perimount plus pericardial bioprosthesis EDWARDS LIFESCIENCES, LLC. P860057 S011 08/28/2000
carpentier-edwards perimount pericardial valve EDWARDS LIFESCIENCES, LLC. P860057 S014 08/04/2000
carpentier-edwards perimount pericardial valve, models 2700 ... EDWARDS LIFESCIENCES, LLC. P860057 S013 06/16/2000
carpentier edwards perimount pericardial bioprosthesis EDWARDS LIFESCIENCES, LLC. P860057 S012 10/22/1999
carpentier-edwards perimount pericardial valve EDWARDS LIFESCIENCES, LLC. P860057 S010 04/13/1999
carpentier-edwards perimount pericardial valve models 2700 a... EDWARDS LIFESCIENCES, LLC. P860057 S009 10/26/1998
carpentier-edwards(r) perimount(tm) bioprosthesis, model 270... EDWARDS LIFESCIENCES, LLC. P860057 S006 08/26/1998
carpentier-edwards(r) pericardial bioprosthesis, model 2700 EDWARDS LIFESCIENCES, LLC. P860057 S003 12/06/1996
carpentier-edwards(r) perimount(tm) bioprosthesis, model 270... EDWARDS LIFESCIENCES, LLC. P860057 S004 10/17/1996
carpentier-edwards pericardial bioprosthesis, model 2700 EDWARDS LIFESCIENCES, LLC. P860057 S001 01/04/1996
edwards lifesciences perimount aortic and mitral bioprosthes... EDWARDS LIFESCIENCES, LLC. P860057 09/26/1991
 
 
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