Carpentier-Edwards Perimount Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process, Theon RSR Pericardial

Replacement Heart-valve

FDA Premarket Approval P860057 S193

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Supplier southington tool and manufacturing corporation (stmc) to perform wireform crimping and tensile test verification.

DeviceCarpentier-Edwards Perimount Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process, Theon RSR Pericardial
Classification NameReplacement Heart-valve
Generic NameReplacement Heart-valve
ApplicantEDWARDS LIFESCIENCES, LLC.
Date Received2019-10-28
Decision Date2019-11-18
PMAP860057
SupplementS193
Product CodeDYE
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address EDWARDS LIFESCIENCES, LLC. one Edwards Way irvine, CA 92614

Supplemental Filings

Supplement NumberDateSupplement Type
P860057Original Filing
S194 2019-11-01 30-day Notice
S193 2019-10-28 30-day Notice
S192 2019-10-18 30-day Notice
S191 2019-08-27 30-day Notice
S190 2019-05-31 30-day Notice
S189
S188
S187 2019-01-31 30-day Notice
S186 2018-11-14 30-day Notice
S185 2018-11-07 30-day Notice
S184 2018-10-31 30-day Notice
S183 2018-10-24 30-day Notice
S182 2018-07-16 30-day Notice
S181 2018-07-11 30-day Notice
S180 2018-07-09 30-day Notice
S179 2018-05-25 30-day Notice
S178 2018-04-23 30-day Notice
S177 2018-03-13 30-day Notice
S176 2018-03-01 30-day Notice
S175 2018-02-28 30-day Notice
S174 2018-02-15 30-day Notice
S173 2018-01-09 30-day Notice
S172 2017-11-13 135 Review Track For 30-day Notice
S171 2017-11-09 30-day Notice
S170 2017-10-31 30-day Notice
S169 2017-09-27 135 Review Track For 30-day Notice
S168 2017-08-09 30-day Notice
S167 2017-07-25 30-day Notice
S166 2017-06-30 30-day Notice
S165 2017-06-22 30-day Notice
S164 2017-06-19 30-day Notice
S163 2017-05-24 30-day Notice
S162 2017-05-12 30-day Notice
S161
S160 2017-04-25 30-day Notice
S159 2017-04-10 30-day Notice
S158 2017-03-23 30-day Notice
S157 2017-01-11 30-day Notice
S156 2016-12-12 135 Review Track For 30-day Notice
S155
S154 2016-11-15 135 Review Track For 30-day Notice
S153 2016-08-22 30-day Notice
S152 2016-08-12 Real-time Process
S151 2016-06-10 30-day Notice
S150 2016-06-10 30-day Notice
S149 2016-05-24 30-day Notice
S148
S147 2016-04-12 135 Review Track For 30-day Notice
S146 2016-04-12 30-day Notice
S145 2016-03-01 30-day Notice
S144 2016-02-18 30-day Notice
S143 2016-02-17 30-day Notice
S142 2016-02-09 135 Review Track For 30-day Notice
S141 2016-01-15 30-day Notice
S140
S139 2015-09-30 30-day Notice
S138 2015-07-27 30-day Notice
S137 2015-05-22 30-day Notice
S136 2015-03-25 30-day Notice
S135 2015-03-23 Real-time Process
S134 2015-03-17 30-day Notice
S133
S132 2015-01-13 30-day Notice
S131 2015-01-08 30-day Notice
S130 2014-12-22 Special (immediate Track)
S129 2014-10-17 30-day Notice
S128 2014-09-04 30-day Notice
S127 2014-07-17 135 Review Track For 30-day Notice
S126 2014-05-23 Real-time Process
S125 2014-05-23 30-day Notice
S124 2014-04-15 30-day Notice
S123 2014-04-01 30-day Notice
S122 2014-03-31 30-day Notice
S121 2014-03-05 Real-time Process
S120 2014-02-27 30-day Notice
S119 2014-02-25 30-day Notice
S118 2014-01-29 135 Review Track For 30-day Notice
S117 2013-12-24 30-day Notice
S116 2013-11-27 Normal 180 Day Track No User Fee
S115 2013-11-22 30-day Notice
S114 2013-10-29 30-day Notice
S113 2013-09-12 30-day Notice
S112 2013-08-26 30-day Notice
S111 2013-08-20 30-day Notice
S110 2013-07-12 30-day Notice
S109 2013-05-29 30-day Notice
S108 2013-05-16 Special (immediate Track)
S107 2013-03-25 30-day Notice
S106 2013-03-15 30-day Notice
S105 2013-02-13 30-day Notice
S104 2013-02-12 Special (immediate Track)
S103 2013-01-17 30-day Notice
S102 2013-01-07 30-day Notice
S101 2012-12-14 30-day Notice
S100 2012-12-14 Normal 180 Day Track
S099 2012-11-30 30-day Notice
S098 2012-11-28 135 Review Track For 30-day Notice
S097 2012-11-21 30-day Notice
S096 2012-11-13 30-day Notice
S095 2012-11-09 30-day Notice
S094 2012-10-22 30-day Notice
S093 2012-10-15 30-day Notice
S092 2012-09-04 30-day Notice
S091 2012-08-21 30-day Notice
S090 2012-06-13 30-day Notice
S089 2012-05-04 30-day Notice
S088 2012-04-17 30-day Notice
S087 2012-03-19 30-day Notice
S086 2012-02-21 30-day Notice
S085 2012-01-25 30-day Notice
S084
S083 2011-12-23 30-day Notice
S082 2011-12-20 30-day Notice
S081 2011-11-16 30-day Notice
S080
S079 2011-05-09 135 Review Track For 30-day Notice
S078 2011-04-08 30-day Notice
S077
S076 2011-02-10 30-day Notice
S075 2010-12-21 30-day Notice
S074 2010-11-24 30-day Notice
S073 2010-11-22 30-day Notice
S072 2010-11-12 135 Review Track For 30-day Notice
S071 2010-09-24 Normal 180 Day Track No User Fee
S070 2010-08-23 30-day Notice
S069 2010-06-11 30-day Notice
S068 2010-04-26 Real-time Process
S067 2010-01-25 30-day Notice
S066 2010-01-21 30-day Notice
S065 2010-01-12 Normal 180 Day Track No User Fee
S064 2009-12-14 30-day Notice
S063 2009-12-07 Normal 180 Day Track No User Fee
S062 2009-11-06 Real-time Process
S061 2009-10-19 30-day Notice
S060 2009-10-09 30-day Notice
S059 2009-07-29 Normal 180 Day Track No User Fee
S058 2009-06-24 30-day Notice
S057 2009-06-09 Normal 180 Day Track No User Fee
S056 2009-05-01 Normal 180 Day Track No User Fee
S055 2009-03-24 Normal 180 Day Track No User Fee
S054 2008-12-22 Real-time Process
S053 2008-12-17 Real-time Process
S052 2008-11-28 30-day Notice
S051 2008-11-28 Real-time Process
S050 2008-10-02 30-day Notice
S049
S048 2008-06-20 30-day Notice
S047 2008-06-12 30-day Notice
S046 2008-05-21 30-day Notice
S045 2008-03-24 Real-time Process
S044 2007-11-15 30-day Notice
S043
S042 2007-07-09 Normal 180 Day Track
S041 2006-10-27 Real-time Process
S040 2006-10-02 Normal 180 Day Track No User Fee
S039 2006-09-26 Real-time Process
S038 2006-08-30 135 Review Track For 30-day Notice
S037 2006-09-25 Real-time Process
S036 2006-07-19 Normal 180 Day Track
S035 2006-06-22 30-day Notice
S034 2006-04-17 30-day Notice
S033 2006-03-16 Real-time Process
S032 2006-03-03 Real-time Process
S031 2005-11-14 Special (immediate Track)
S030 2005-08-19 Real-time Process
S029 2005-07-18 Normal 180 Day Track
S028 2005-04-28 30-day Notice
S027 2005-03-21 30-day Notice
S026 2005-01-31 30-day Notice
S025 2004-12-20 30-day Notice
S024 2004-09-27 135 Review Track For 30-day Notice
S023 2004-07-27 Real-time Process
S022 2003-06-20 Normal 180 Day Track
S021 2003-03-26 Special (immediate Track)
S020 2002-12-05 30-day Notice
S019 2002-11-12 Normal 180 Day Track
S018 2001-10-02 Normal 180 Day Track
S017 2001-01-08 Normal 180 Day Track
S016 2000-11-17 Normal 180 Day Track
S015 2000-10-10 Normal 180 Day Track
S014 2000-07-13 30-day Notice
S013 2000-05-18 30-day Notice
S012 1999-10-04 30-day Notice
S011 1999-04-22 Panel Track
S010 1999-03-26 30-day Notice
S009 1998-10-09 30-day Notice
S008
S007
S006 1997-11-28 Normal 180 Day Track
S005
S004 1996-04-17 Normal 180 Day Track
S003 1995-10-30 Normal 180 Day Track
S002
S001 1994-08-22 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
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