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 addition of a post-fixation tissue heat treatment step in glutaraldehyde solution prior to the edwards xenologix tissue valve processing steps. The devices, as modified, will be marketed with the reference to thermafix as the trademark/brand name for the tissue processing method and will be identified according to the following modified model numbers: models 2700tfx, 2800tfx, 6900ptfx, and 3000tfx.
| Device | PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2800 (PERIMOUNT RSR), 6900P (PERIMOUNT PLUS) AND 3000 |
| Classification Name | Replacement Heart-valve |
| Generic Name | Replacement Heart-valve |
| Applicant | EDWARDS LIFESCIENCES, LLC. |
| Date Received | 2003-06-20 |
| Decision Date | 2004-01-26 |
| PMA | P860057 |
| Supplement | S022 |
| Product Code | DYE |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| 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 |