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 alternate manufacturing site for assembly of the external products (programmers, software modules/disks, external cardioverter defibrillators, and related accessories) which are used with dpi pacemaker and aicd systems. The proposed alternate manufacturing site (cardigan facility) is located at the following address: cpi cardigan facility, 599 cardigan road, shoreview, minnesota 55126
| Device | VENTAK(R) PRX (TM) II AICD SYSTEM |
| Classification Name | Implantable Cardioverter Defibrillator (non-crt) |
| Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
| Applicant | BOSTON SCIENTIFIC |
| Date Received | 1995-04-06 |
| Decision Date | 1995-11-20 |
| PMA | P910077 |
| Supplement | S007 |
| Product Code | LWS |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| 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 |