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.
To adjust bioburden action limit and alert levels at the sylmar manufacturing site
| Device | Durata, Durata (MR Conditional), Optisure, Optisure (MR Conditional) |
| Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
| Applicant | Abbott Medical |
| Date Received | 2021-06-28 |
| Decision Date | 2021-07-07 |
| PMA | P950022 |
| Supplement | S139 |
| Product Code | LWS |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Medical 15900 Valley View Court sylmar, CA 91335 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P950022 | Original Filing | |
| S143 | 2022-07-14 | 30-day Notice |
| S142 | 2021-10-15 | Normal 180 Day Track No User Fee |
| S141 | 2021-08-02 | 30-day Notice |
| S140 | 2021-07-01 | 30-day Notice |
| S139 | 2021-06-28 | 30-day Notice |
| S138 | 2021-03-12 | 30-day Notice |
| S137 | 2020-11-25 | 30-day Notice |
| S136 | 2020-10-21 | 30-day Notice |
| S135 | 2020-08-11 | Real-time Process |
| S134 | 2020-06-01 | 30-day Notice |
| S133 | 2020-05-22 | 30-day Notice |
| S132 | 2020-05-08 | Normal 180 Day Track No User Fee |
| S131 | 2020-03-12 | Normal 180 Day Track No User Fee |
| S130 | 2020-02-27 | 30-day Notice |
| S129 | 2020-01-27 | 30-day Notice |
| S128 | 2019-09-27 | 30-day Notice |
| S127 | ||
| S126 | 2018-11-30 | 30-day Notice |
| S125 | 2018-11-23 | 30-day Notice |
| S124 | 2018-11-20 | 30-day Notice |
| S123 | 2018-10-02 | 30-day Notice |
| S122 | 2018-10-01 | 30-day Notice |
| S121 | 2018-09-28 | 30-day Notice |
| S120 | 2018-07-02 | 30-day Notice |
| S119 | 2018-04-02 | Real-time Process |
| S118 | 2018-03-05 | 30-day Notice |
| S117 | 2018-02-27 | 30-day Notice |
| S116 | 2018-02-26 | 30-day Notice |
| S115 | 2018-01-31 | 30-day Notice |
| S114 | 2018-01-26 | 30-day Notice |
| S113 | 2017-12-21 | 30-day Notice |
| S112 | ||
| S111 | 2017-09-22 | 30-day Notice |
| S110 | 2017-07-28 | Real-time Process |
| S109 | 2017-07-03 | Normal 180 Day Track |
| S108 | 2017-06-27 | 30-day Notice |
| S107 | 2017-06-16 | Normal 180 Day Track |
| S106 | 2017-05-24 | 30-day Notice |
| S105 | 2017-04-03 | Normal 180 Day Track |
| S104 | 2017-02-28 | 30-day Notice |
| S103 | 2017-02-24 | 30-day Notice |
| S102 | 2017-02-17 | 135 Review Track For 30-day Notice |
| S101 | 2017-02-10 | 30-day Notice |
| S100 | 2017-01-26 | 30-day Notice |
| S099 | 2017-01-25 | 30-day Notice |
| S098 | 2016-12-13 | 30-day Notice |
| S097 | 2016-11-08 | 30-day Notice |
| S096 | 2016-10-12 | 30-day Notice |
| S095 | 2016-09-27 | 135 Review Track For 30-day Notice |
| S094 | ||
| S093 | 2016-06-22 | 30-day Notice |
| S092 | 2016-04-12 | 30-day Notice |
| S091 | 2016-01-19 | 30-day Notice |
| S090 | 2015-12-15 | 30-day Notice |
| S089 | 2015-10-26 | 135 Review Track For 30-day Notice |
| S088 | 2015-08-10 | 30-day Notice |
| S087 | 2014-09-29 | 30-day Notice |
| S086 | 2013-05-02 | 30-day Notice |
| S085 | 2012-10-24 | Normal 180 Day Track |
| S084 | 2012-09-13 | 30-day Notice |
| S083 | 2012-09-05 | Real-time Process |
| S082 | ||
| S081 | 2012-01-09 | 135 Review Track For 30-day Notice |
| S080 | 2011-11-30 | 135 Review Track For 30-day Notice |
| S079 | 2011-11-07 | Normal 180 Day Track |
| S078 | 2011-09-20 | Real-time Process |
| S077 | 2011-06-20 | Real-time Process |
| S076 | 2011-01-27 | 30-day Notice |
| S075 | 2010-10-21 | Real-time Process |
| S074 | 2010-08-16 | Normal 180 Day Track No User Fee |
| S073 | 2010-07-13 | Normal 180 Day Track No User Fee |
| S072 | 2010-06-30 | 135 Review Track For 30-day Notice |
| S071 | 2010-06-15 | 30-day Notice |
| S070 | 2010-04-30 | Real-time Process |
| S069 | 2010-04-22 | Normal 180 Day Track |
| S068 | 2009-12-24 | 30-day Notice |
| S067 | 2009-11-25 | Normal 180 Day Track No User Fee |
| S066 | ||
| S065 | ||
| S064 | 2009-08-28 | 30-day Notice |
| S063 | 2009-08-04 | Real-time Process |
| S062 | 2009-06-10 | 30-day Notice |
| S061 | 2009-06-03 | 30-day Notice |
| S060 | 2009-05-14 | Real-time Process |
| S059 | ||
| S058 | 2009-02-06 | Normal 180 Day Track No User Fee |
| S057 | 2009-01-30 | 30-day Notice |
| S056 | 2009-01-21 | Normal 180 Day Track No User Fee |
| S055 | 2009-01-14 | 135 Review Track For 30-day Notice |
| S054 | 2008-09-29 | 135 Review Track For 30-day Notice |
| S053 | 2008-05-21 | 30-day Notice |
| S052 | 2008-05-07 | Real-time Process |
| S051 | 2008-02-01 | Normal 180 Day Track No User Fee |
| S050 | 2008-01-15 | 30-day Notice |
| S049 | 2007-12-03 | Normal 180 Day Track No User Fee |
| S048 | 2007-11-19 | 30-day Notice |
| S047 | 2007-11-19 | 30-day Notice |
| S046 | 2007-11-05 | 135 Review Track For 30-day Notice |
| S045 | 2007-10-19 | Normal 180 Day Track No User Fee |
| S044 | ||
| S043 | 2007-09-20 | 30-day Notice |
| S042 | 2007-09-05 | Normal 180 Day Track |
| S041 | 2007-08-22 | Real-time Process |
| S040 | 2007-07-06 | Real-time Process |
| S039 | 2007-05-10 | 30-day Notice |
| S038 | 2007-05-09 | 30-day Notice |
| S037 | 2007-02-26 | 30-day Notice |
| S036 | 2007-02-26 | 30-day Notice |
| S035 | 2007-02-21 | 30-day Notice |
| S034 | 2006-12-19 | Real-time Process |
| S033 | 2006-11-15 | 135 Review Track For 30-day Notice |
| S032 | 2006-11-02 | Real-time Process |
| S031 | 2006-10-16 | 30-day Notice |
| S030 | 2006-06-05 | Real-time Process |
| S029 | ||
| S028 | 2006-02-13 | Real-time Process |
| S027 | 2006-02-10 | Real-time Process |
| S026 | 2005-08-15 | 30-day Notice |
| S025 | 2005-05-31 | Normal 180 Day Track |
| S024 | 2005-04-21 | Real-time Process |
| S023 | 2005-04-05 | 30-day Notice |
| S022 | 2005-04-05 | 30-day Notice |
| S021 | 2005-04-05 | 30-day Notice |
| S020 | 2005-04-05 | 30-day Notice |
| S019 | 2005-03-25 | Real-time Process |
| S018 | 2004-03-11 | Real-time Process |
| S017 | 2003-06-09 | Real-time Process |
| S016 | 2002-12-31 | Real-time Process |
| S015 | 2002-12-04 | Real-time Process |
| S014 | 2002-01-31 | Real-time Process |
| S013 | 2001-08-10 | Normal 180 Day Track |
| S012 | 2000-12-19 | 30-day Notice |
| S011 | 2000-08-17 | Normal 180 Day Track |
| S010 | 2000-08-11 | Normal 180 Day Track |
| S009 | 2000-06-08 | Real-time Process |
| S008 | 2000-03-20 | 30-day Notice |
| S007 | 1999-12-14 | Real-time Process |
| S006 | 1999-05-24 | Normal 180 Day Track |
| S005 | 1999-02-08 | Normal 180 Day Track |
| S004 | 1998-11-23 | Real-time Process |
| S003 | 1998-08-20 | Normal 180 Day Track |
| S002 | 1997-04-14 | Normal 180 Day Track |
| S001 | 1996-10-15 | Normal 180 Day Track |