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 a name change to the carpentier-edwards perimount bioprosthesis, model 2700, and approval for a reduced sewing ring (rsr) version of the valve which will be named the carpentier-edwards perimount rsr bioprosthesis, model 2800 and approval for the use of the current model 1161 valve sizers with the model 2800 valve, and approval for a new set of valve sizers, model 1127, for use with the model 2700 valve. The approval also discontinues the use fo the current device name, the carpentier-edwards pericardial bioprosthesis. The device, as modified, will be marketed under the trade anem carpentier-edwards perimount bioprosthesis, model 2700, and carpentier-edwards perimount rsr bioprosthesis, model 2800 and will continue to use the same indications for use and remain available in the aortic sizes of 19, 21, 23, 25, 27, and 29mm
| Device | CARPENTIER-EDWARDS PERICARDIAL BIOPROSTHESIS, MODEL 2700 |
| Classification Name | Replacement Heart-valve |
| Generic Name | Replacement Heart-valve |
| Applicant | EDWARDS LIFESCIENCES, LLC. |
| Date Received | 1994-08-22 |
| Decision Date | 1996-01-04 |
| PMA | P860057 |
| Supplement | S001 |
| Product Code | DYE |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |