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 changes to the indications for use and clinical study section labeling. The devices are indicated for: for icds (ventak prx, mini, vitality, ventak av and prizm): guidant icds are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. For vitality avt:guidant vitality avt is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. This device is also intended to provide atrial antitachycardia pacing and atrial defibrillation treatment in patients who have or are at risk of developing atrial tachyarrhythmias. For crt-ds (contak cd and renewal):guidant cardiac resynchronization therapy defibrillators (crt-ds) are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. Guidant crt-ds are also indicated for reduction of symptoms of moderate to severe heart failure (nyha iii/iv) in patients who remain symptomatic despite stable, optimal heart failure drug therapy, and have left ventricular dysfunction (ef = 120 ms.
| Device | VENTAK AV, PRIZM, VITALITY, VITALITY AVT IMPLANTABLE CARDIOVERTER DEFIBRILLATORS |
| Classification Name | Implantable Cardioverter Defibrillator (non-crt) |
| Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
| Applicant | BOSTON SCIENTIFIC |
| Date Received | 2003-11-13 |
| Decision Date | 2004-02-06 |
| PMA | P910077 |
| Supplement | S041 |
| Product Code | LWS |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BOSTON SCIENTIFIC 4100 Hamline Avenue North st. Paul, MN 55112 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P910077 | Original Filing | |
| S190 | 2022-11-16 | 30-day Notice |
| S189 | 2022-11-01 | 30-day Notice |
| S188 | ||
| S187 | 2021-12-01 | Real-time Process |
| S186 | 2021-09-03 | Real-time Process |
| S185 | 2021-06-21 | Real-time Process |
| S184 | 2021-04-30 | 30-day Notice |
| S183 | 2021-03-08 | 30-day Notice |
| S182 | 2020-11-17 | Real-time Process |
| S181 | 2020-08-24 | 30-day Notice |
| S180 | ||
| S179 | 2020-05-14 | 30-day Notice |
| S178 | ||
| S177 | ||
| S176 | 2020-01-03 | Real-time Process |
| S175 | 2019-10-28 | 30-day Notice |
| S174 | ||
| S173 | 2019-07-22 | Real-time Process |
| S172 | 2019-04-10 | Real-time Process |
| S171 | 2019-03-20 | Real-time Process |
| S170 | 2019-03-13 | 30-day Notice |
| S169 | ||
| S168 | 2018-12-03 | Real-time Process |
| S167 | 2018-07-18 | Normal 180 Day Track No User Fee |
| S166 | 2018-03-26 | 30-day Notice |
| S165 | 2018-01-18 | Real-time Process |
| S164 | 2017-12-14 | Real-time Process |
| S163 | 2017-10-20 | Real-time Process |
| S162 | 2017-09-15 | Real-time Process |
| S161 | 2017-05-26 | Normal 180 Day Track |
| S160 | 2017-05-22 | Real-time Process |
| S159 | 2017-04-03 | Normal 180 Day Track |
| S158 | 2017-02-17 | Real-time Process |
| S157 | 2016-11-22 | Real-time Process |
| S156 | 2016-10-26 | Normal 180 Day Track |
| S155 | 2016-10-19 | Normal 180 Day Track |
| S154 | 2016-06-16 | Normal 180 Day Track |
| S153 | 2016-05-27 | 30-day Notice |
| S152 | 2016-04-21 | Real-time Process |
| S151 | 2015-12-21 | Real-time Process |
| S150 | 2015-06-29 | 30-day Notice |
| S149 | 2015-04-27 | Real-time Process |
| S148 | 2014-11-20 | Real-time Process |
| S147 | 2014-09-05 | Real-time Process |
| S146 | 2014-08-15 | 30-day Notice |
| S145 | 2014-06-30 | 30-day Notice |
| S144 | 2014-06-09 | Real-time Process |
| S143 | 2014-05-27 | Real-time Process |
| S142 | 2014-04-22 | 30-day Notice |
| S141 | 2014-02-21 | Real-time Process |
| S140 | 2013-11-20 | Normal 180 Day Track |
| S139 | 2013-09-30 | Normal 180 Day Track |
| S138 | 2013-09-25 | Normal 180 Day Track |
| S137 | 2013-08-29 | 30-day Notice |
| S136 | 2013-07-22 | 30-day Notice |
| S135 | 2013-05-23 | 30-day Notice |
| S134 | 2013-05-17 | Real-time Process |
| S133 | 2013-05-16 | Real-time Process |
| S132 | 2013-02-12 | 30-day Notice |
| S131 | 2013-02-08 | Real-time Process |
| S130 | 2013-01-03 | Real-time Process |
| S129 | 2012-11-08 | 30-day Notice |
| S128 | 2012-10-15 | 30-day Notice |
| S127 | 2012-10-12 | 30-day Notice |
| S126 | 2012-10-02 | 30-day Notice |
| S125 | 2012-09-28 | 30-day Notice |
| S124 | 2012-09-25 | 30-day Notice |
| S123 | 2012-07-27 | Real-time Process |
| S122 | 2012-07-26 | Real-time Process |
| S121 | 2012-05-09 | Real-time Process |
| S120 | 2012-03-26 | 30-day Notice |
| S119 | 2012-02-09 | Normal 180 Day Track |
| S118 | 2012-01-24 | 30-day Notice |
| S117 | 2011-08-03 | 30-day Notice |
| S116 | 2011-05-25 | 30-day Notice |
| S115 | 2011-05-12 | Real-time Process |
| S114 | ||
| S113 | 2011-04-01 | 30-day Notice |
| S112 | 2011-03-31 | 30-day Notice |
| S111 | 2011-04-04 | Real-time Process |
| S110 | 2011-01-24 | Real-time Process |
| S109 | 2010-09-24 | Real-time Process |
| S108 | 2010-08-23 | Real-time Process |
| S107 | 2010-07-27 | 30-day Notice |
| S106 | 2010-07-15 | 30-day Notice |
| S105 | 2010-06-22 | 30-day Notice |
| S104 | 2010-03-24 | Real-time Process |
| S103 | 2010-03-02 | 30-day Notice |
| S102 | 2010-02-05 | Real-time Process |
| S101 | 2009-12-18 | 30-day Notice |
| S100 | 2009-12-16 | 30-day Notice |
| S099 | ||
| S098 | 2009-10-16 | 30-day Notice |
| S097 | 2009-09-30 | Real-time Process |
| S096 | 2009-06-17 | 135 Review Track For 30-day Notice |
| S095 | 2009-06-11 | 30-day Notice |
| S094 | 2009-05-26 | Real-time Process |
| S093 | 2009-03-16 | Real-time Process |
| S092 | 2009-03-04 | Real-time Process |
| S091 | 2008-07-23 | Real-time Process |
| S090 | 2008-07-22 | Normal 180 Day Track |
| S089 | 2008-06-18 | 30-day Notice |
| S088 | 2008-06-03 | 30-day Notice |
| S087 | 2008-05-23 | Real-time Process |
| S086 | 2008-04-11 | 30-day Notice |
| S085 | ||
| S084 | 2008-02-28 | Real-time Process |
| S083 | 2007-12-11 | Real-time Process |
| S082 | ||
| S081 | 2007-11-09 | 30-day Notice |
| S080 | 2007-10-11 | 30-day Notice |
| S079 | 2007-09-19 | 30-day Notice |
| S078 | 2007-09-07 | Real-time Process |
| S077 | 2007-09-05 | Normal 180 Day Track |
| S076 | 2007-08-23 | Normal 180 Day Track |
| S075 | 2007-05-24 | Normal 180 Day Track No User Fee |
| S074 | 2007-02-23 | Real-time Process |
| S073 | 2007-02-22 | Real-time Process |
| S072 | 2007-02-08 | Special (immediate Track) |
| S071 | 2007-01-16 | Real-time Process |
| S070 | ||
| S069 | ||
| S068 | 2007-01-11 | Real-time Process |
| S067 | 2006-11-06 | 30-day Notice |
| S066 | 2006-11-01 | Real-time Process |
| S065 | ||
| S064 | ||
| S063 | 2006-06-26 | 30-day Notice |
| S062 | 2006-05-25 | Special (immediate Track) |
| S061 | 2006-04-18 | Normal 180 Day Track |
| S060 | 2006-04-13 | 30-day Notice |
| S059 | 2006-04-13 | 30-day Notice |
| S058 | 2006-03-28 | 30-day Notice |
| S057 | 2005-12-15 | Real-time Process |
| S056 | 2005-11-22 | 135 Review Track For 30-day Notice |
| S055 | 2005-10-31 | Real-time Process |
| S054 | 2005-10-11 | Real-time Process |
| S053 | 2005-10-11 | 135 Review Track For 30-day Notice |
| S052 | 2005-06-27 | 30-day Notice |
| S051 | 2005-03-15 | Normal 180 Day Track |
| S050 | 2005-03-04 | Normal 180 Day Track |
| S049 | 2004-12-03 | 30-day Notice |
| S048 | 2004-11-19 | Real-time Process |
| S047 | 2004-10-21 | 30-day Notice |
| S046 | 2004-09-01 | Normal 180 Day Track |
| S045 | 2004-04-14 | 30-day Notice |
| S044 | 2004-01-13 | 30-day Notice |
| S043 | 2003-11-26 | Special (immediate Track) |
| S042 | 2003-11-20 | 30-day Notice |
| S041 | 2003-11-13 | Normal 180 Day Track |
| S040 | 2003-07-16 | Normal 180 Day Track |
| S039 | 2002-12-12 | Normal 180 Day Track |
| S038 | 2002-11-13 | 30-day Notice |
| S037 | 2001-12-14 | Panel Track |
| S036 | 2000-12-01 | Real-time Process |
| S035 | 2000-11-07 | Real-time Process |
| S034 | ||
| S033 | 2000-08-21 | Normal 180 Day Track |
| S032 | 2000-01-14 | Real-time Process |
| S031 | 1999-12-20 | Normal 180 Day Track |
| S030 | 1999-12-16 | Normal 180 Day Track |
| S029 | 1999-10-06 | Real-time Process |
| S028 | ||
| S027 | 1999-02-17 | Real-time Process |
| S026 | 1998-12-21 | Real-time Process |
| S025 | 1998-09-10 | Normal 180 Day Track |
| S024 | 1998-10-19 | Real-time Process |
| S023 | 1998-06-24 | Real-time Process |
| S022 | 1997-07-28 | Normal 180 Day Track |
| S021 | 1997-07-18 | Real-time Process |
| S020 | 1996-12-23 | Normal 180 Day Track |
| S019 | 1996-10-16 | Normal 180 Day Track |
| S018 | 1996-08-30 | Normal 180 Day Track |
| S017 | ||
| S016 | 1996-07-09 | Normal 180 Day Track |
| S015 | 1996-05-10 | Normal 180 Day Track |
| S014 | 1996-03-25 | Normal 180 Day Track |
| S013 | ||
| S012 | 1995-09-12 | Normal 180 Day Track |
| S011 | 1995-08-25 | Normal 180 Day Track |
| S010 | 1995-06-26 | Normal 180 Day Track |
| S009 | 1995-06-14 | Normal 180 Day Track |
| S008 | 1995-06-13 | Normal 180 Day Track |
| S007 | 1995-04-06 | Normal 180 Day Track |
| S006 | 1994-12-14 | Normal 180 Day Track |
| S005 | ||
| S004 | 1994-11-07 | Normal 180 Day Track |
| S003 | ||
| S002 | 1994-09-06 | Normal 180 Day Track |
| S001 | 1994-08-05 | Normal 180 Day Track |