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 design and manufacturing modifications to the sewing ring/support assembly components of the model 2800 aortic valve, sizes 19, 21, 23, 25, 27, and 29 mm. The device, as modified, will be marketed under the trade name carpentier-edwards perimount magna pericardial bioprosthesis, model 3000 aortic and is indicated for the replacement of malfunctioning native or prosthetic aortic heart valves using the supra-annular or intra-annular implantation technique.
| Device | CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS, MODEL 3000 AORTIC |
| Classification Name | Replacement Heart-valve |
| Generic Name | Replacement Heart-valve |
| Applicant | EDWARDS LIFESCIENCES, LLC. |
| Date Received | 2001-10-02 |
| Decision Date | 2003-11-14 |
| PMA | P860057 |
| Supplement | S018 |
| 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 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| 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 |