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 addition of the riata st lead models 7000, 7001, and 7002 to the riata defibrillation lead system. The devices, as modified, will be marketed under the trade name riata st models 7000, 7001, and 7002 and are indicated for use with compatible pulse generators.
| Device | RIATA ST LEAD MODELS 7000, 7001, AND 7002 |
| Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
| Applicant | St. Jude Medical, Inc. |
| Date Received | 2005-04-21 |
| Decision Date | 2005-06-03 |
| PMA | P950022 |
| Supplement | S024 |
| Product Code | LWS |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| 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 |