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 to modify the shock coil on the riata st optim and riata sts optim leads and to add two new passive lead models. The devices, as modified, will be marketed under the trade name riata st optim lead models 7020, 7021, 7022, 7030, 7031, 7070 and 7071 and riata sts optim lead models 7120, 7121,7122, 7130, 7131, 7170 and 7171 and are indicated for use with compatible pulse generators (refer to the applicable defibrillator manul for system indications). They provide pacing and sensing and deliver cardioversion/ defibrillation therapy to the heart.
| Device | RIATA ST OPTIM LEADS AND RIATA STS OPTIM LEADS AND |
| Classification Name | Implantable Cardioverter Defibrillator (non-crt) |
| Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
| Applicant | St. Jude Medical, Inc. |
| Date Received | 2007-08-22 |
| Decision Date | 2007-10-16 |
| PMA | P950022 |
| Supplement | S041 |
| Product Code | LWS |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |