This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATOR |
| Classification Name | Implantable Cardioverter Defibrillator (non-crt) |
| Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
| Applicant | BOSTON SCIENTIFIC |
| Date Received | 1991-12-23 |
| Decision Date | 1994-06-17 |
| Notice Date | 1994-08-15 |
| PMA | P910077 |
| Supplement | S |
| Product Code | LWS |
| Docket Number | 94M-0241 |
| Advisory Committee | Cardiovascular |
| 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 |