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 passive fixation durata leads with sj4 four-pole proximal connectors; model numbers 7170q and 7171q.
| Device | DURATA LEAD MODELS |
| Generic Name | Permanent Defibrillator Electrodes |
| Applicant | St. Jude Medical, Inc. |
| Date Received | 2009-05-14 |
| Decision Date | 2009-07-10 |
| PMA | P950022 |
| Supplement | S060 |
| Product Code | NVY |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | St. Jude Medical, Inc. 15900 Valley View Court sylmar, CA 91342 |
| 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 |