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 rv lead model rv03, svc lead models sv04 and sv05 with a solid suture sleeve, stylet models s-70-4, s-70-f, s-45-x, s-55-x and s-70-x and for use of a lser process to remove excess silicone rubber from the defibrillation coils.
| Device | TVL(TM) LEAD SYSTEM |
| Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
| Applicant | St. Jude Medical, Inc. |
| Date Received | 1996-10-15 |
| Decision Date | 1997-04-23 |
| PMA | P950022 |
| Supplement | S001 |
| Product Code | LWS |
| Docket Number | N |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| 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 |