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.
Approval for the trade name change for three devices, the carpentier-edwards perimount pericardial aortic bioprosthesis model 2700tfx trade name change to the carpentier-edwards perimount theon pericardial aortic bioprosthesis model 2700tfx, the carpentier-edwards perimount rsr pericardial aortic bioprosthesis model 2800tfx trade name change to the carpentier-edwards perimount theon rsr pericardial aortic bioprosthesis model 2800tfx, and the carpentier-edwards perimount plus pericardial mitral bioprosthesis model 6900ptfx trade name change to the carpentier-edwards perimount theon pericardial mitral bioprosthesis model 6900ptfx. The indications for the three devices remain unchanged.
| Device | CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS MODEL 2700TFX |
| Classification Name | Replacement Heart-valve |
| Generic Name | Replacement Heart-valve |
| Applicant | EDWARDS LIFESCIENCES, LLC. |
| Date Received | 2006-10-02 |
| Decision Date | 2006-11-08 |
| PMA | P860057 |
| Supplement | S040 |
| Product Code | DYE |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | EDWARDS LIFESCIENCES, LLC. one Edwards Way irvine, CA 92614 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P860057 | Original Filing | |
| S210 | 2022-10-12 | 30-day Notice |
| S209 | 2022-08-25 | 30-day Notice |
| S208 | 2022-08-15 | 30-day Notice |
| S207 | ||
| S206 | 2022-03-08 | 30-day Notice |
| S205 | 2021-10-19 | 30-day Notice |
| S204 | 2021-09-27 | 30-day Notice |
| S203 | 2021-08-11 | 30-day Notice |
| S202 | ||
| S201 | 2020-11-16 | 30-day Notice |
| S200 | 2020-10-28 | 30-day Notice |
| S199 | 2020-02-10 | 30-day Notice |
| S198 | 2020-02-07 | 30-day Notice |
| S197 | ||
| S196 | ||
| S195 | 2019-11-18 | 30-day Notice |
| 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 |