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.
Changing the silicone gasket material (supplied by st. Gobain) for the 3. 8 oz. Jar cap gasket used in the finished-device packaging container for all edwards heart valves.
| Device | CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS |
| Classification Name | Replacement Heart-valve |
| Generic Name | Replacement Heart-valve |
| Applicant | EDWARDS LIFESCIENCES, LLC. |
| Date Received | 2013-08-26 |
| Decision Date | 2013-09-23 |
| PMA | P860057 |
| Supplement | S112 |
| 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 | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |