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 1) design modifications to the suture sleeve of all commercially available durata leads; 2) 7f suture sleeve accessory kit compatible with all sjm 7f leads; 3) reduction in pvp (fastpass) coating length for all dual-shock versions of commercially available durata leads; and 4) design modifications to the is-1 connector crimp connection for all trifurcated versions of the commercially- available durata leads.
Device | DURATA FAMILY OF LEADS |
Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
Applicant | St. Jude Medical, Inc. |
Date Received | 2010-04-22 |
Decision Date | 2011-01-24 |
PMA | P950022 |
Supplement | S069 |
Product Code | LWS |
Advisory Committee | Cardiovascular |
Supplement Type | Normal 180 Day Track |
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 |
Approval Order: | Approval Order |
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 |