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.
Update the bsc2000-2 cycle conducted in chamber 5 at the bsc coventry, ri facility with new programmable logic controller (plc) software, a replacement vacuum pump with an additional vacuum pump booster, and a new validation documentation structure used to support the system.
| Device | Rotablator Rotational Atherectomy System |
| Classification Name | Catheter, Coronary, Atherectomy |
| Generic Name | Catheter, Coronary, Atherectomy |
| Applicant | Boston Scientific Corp. |
| Date Received | 2017-10-30 |
| Decision Date | 2017-12-01 |
| PMA | P900056 |
| Supplement | S168 |
| Product Code | MCX |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Corp. two Scimed Place maple Grove, MN 55311-1566 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P900056 | Original Filing | |
| S204 | 2023-01-06 | 30-day Notice |
| S203 | 2022-10-17 | 30-day Notice |
| S202 | 2022-09-19 | 30-day Notice |
| S201 | ||
| S200 | 2022-04-11 | 135 Review Track For 30-day Notice |
| S199 | 2022-03-30 | 30-day Notice |
| S198 | 2022-03-07 | 30-day Notice |
| S197 | 2022-01-28 | 30-day Notice |
| S196 | 2021-11-08 | Real-time Process |
| S195 | 2021-10-28 | 30-day Notice |
| S194 | 2021-09-08 | 30-day Notice |
| S193 | 2021-06-07 | 30-day Notice |
| S192 | 2021-05-28 | 30-day Notice |
| S191 | 2020-10-22 | Normal 180 Day Track No User Fee |
| S190 | 2020-09-17 | 30-day Notice |
| S189 | ||
| S188 | ||
| S187 | 2020-08-12 | 30-day Notice |
| S186 | 2020-06-17 | 30-day Notice |
| S185 | 2020-05-22 | 30-day Notice |
| S184 | 2020-03-12 | Normal 180 Day Track No User Fee |
| S183 | ||
| S182 | ||
| S181 | 2019-11-01 | Normal 180 Day Track |
| S180 | 2019-10-25 | 30-day Notice |
| S179 | 2019-10-10 | 30-day Notice |
| S178 | 2019-05-03 | 30-day Notice |
| S177 | 2019-03-22 | 30-day Notice |
| S176 | 2019-03-18 | Real-time Process |
| S175 | ||
| S174 | 2018-11-19 | Real-time Process |
| S173 | 2018-08-24 | 30-day Notice |
| S172 | 2018-06-13 | 30-day Notice |
| S171 | 2018-06-05 | 30-day Notice |
| S170 | 2018-04-06 | 135 Review Track For 30-day Notice |
| S169 | 2018-01-17 | 30-day Notice |
| S168 | 2017-10-30 | 30-day Notice |
| S167 | 2017-10-02 | 30-day Notice |
| S166 | 2017-09-07 | Normal 180 Day Track |
| S165 | 2017-08-07 | Real-time Process |
| S164 | 2017-08-04 | 30-day Notice |
| S163 | 2017-07-18 | 30-day Notice |
| S162 | 2017-06-26 | 30-day Notice |
| S161 | 2017-04-28 | 30-day Notice |
| S160 | 2017-04-13 | 30-day Notice |
| S159 | 2017-04-04 | 30-day Notice |
| S158 | 2017-03-06 | 30-day Notice |
| S157 | 2017-02-06 | Normal 180 Day Track No User Fee |
| S156 | 2016-12-02 | 30-day Notice |
| S155 | 2016-09-12 | 30-day Notice |
| S154 | 2016-07-21 | 30-day Notice |
| S153 | 2016-04-25 | 30-day Notice |
| S152 | 2016-02-12 | 30-day Notice |
| S151 | 2015-09-10 | 30-day Notice |
| S150 | 2015-07-23 | 30-day Notice |
| S149 | 2015-06-15 | 30-day Notice |
| S148 | ||
| S147 | 2015-05-14 | 30-day Notice |
| S146 | 2015-04-29 | 30-day Notice |
| S145 | 2015-03-23 | Real-time Process |
| S144 | 2014-12-16 | 135 Review Track For 30-day Notice |
| S143 | 2014-11-12 | 30-day Notice |
| S142 | 2014-07-03 | 30-day Notice |
| S141 | ||
| S140 | 2014-06-25 | 30-day Notice |
| S139 | 2014-06-13 | Normal 180 Day Track No User Fee |
| S138 | 2014-04-07 | 30-day Notice |
| S137 | 2014-03-31 | 30-day Notice |
| S136 | 2014-03-28 | 30-day Notice |
| S135 | 2014-03-28 | 30-day Notice |
| S134 | 2014-03-19 | 30-day Notice |
| S133 | 2014-02-24 | 30-day Notice |
| S132 | 2014-02-03 | Normal 180 Day Track |
| S131 | 2014-01-14 | 30-day Notice |
| S130 | 2014-01-03 | 30-day Notice |
| S129 | 2013-11-21 | 30-day Notice |
| S128 | 2013-09-20 | 30-day Notice |
| S127 | 2013-09-19 | 30-day Notice |
| S126 | 2013-08-29 | 30-day Notice |
| S125 | 2013-08-12 | 30-day Notice |
| S124 | 2013-06-10 | 30-day Notice |
| S123 | 2013-06-10 | 135 Review Track For 30-day Notice |
| S122 | 2013-05-21 | 30-day Notice |
| S121 | 2013-02-14 | 135 Review Track For 30-day Notice |
| S120 | 2013-01-15 | 30-day Notice |
| S119 | 2012-12-26 | 30-day Notice |
| S118 | 2012-11-19 | 30-day Notice |
| S117 | 2012-11-16 | 30-day Notice |
| S116 | 2012-06-06 | 30-day Notice |
| S115 | 2012-05-25 | 30-day Notice |
| S114 | 2012-04-27 | 30-day Notice |
| S113 | 2012-03-23 | 30-day Notice |
| S112 | 2012-02-16 | 30-day Notice |
| S111 | 2011-11-07 | 30-day Notice |
| S110 | 2011-11-07 | 30-day Notice |
| S109 | 2011-08-16 | 30-day Notice |
| S108 | 2011-07-29 | 30-day Notice |
| S107 | 2011-06-21 | Normal 180 Day Track No User Fee |
| S106 | 2011-06-15 | Normal 180 Day Track No User Fee |
| S105 | ||
| S104 | 2011-04-01 | Normal 180 Day Track No User Fee |
| S103 | 2010-10-07 | 135 Review Track For 30-day Notice |
| S102 | 2010-07-27 | 30-day Notice |
| S101 | 2010-08-17 | Real-time Process |
| S100 | 2010-05-25 | 30-day Notice |
| S099 | 2010-03-08 | 135 Review Track For 30-day Notice |
| S098 | 2010-02-05 | 135 Review Track For 30-day Notice |
| S097 | 2010-01-26 | 30-day Notice |
| S096 | 2009-04-24 | 30-day Notice |
| S095 | 2008-09-23 | 135 Review Track For 30-day Notice |
| S094 | 2008-09-09 | Normal 180 Day Track |
| S093 | 2008-05-23 | 135 Review Track For 30-day Notice |
| S092 | 2008-05-13 | Special (immediate Track) |
| S091 | 2008-04-29 | 30-day Notice |
| S090 | 2007-06-19 | Real-time Process |
| S089 | 2007-05-07 | Normal 180 Day Track No User Fee |
| S088 | 2006-05-09 | 30-day Notice |
| S087 | ||
| S086 | 2005-10-12 | Real-time Process |
| S085 | ||
| S084 | 2005-04-25 | Special (immediate Track) |
| S083 | 2005-04-11 | Normal 180 Day Track No User Fee |
| S082 | 2004-12-27 | Real-time Process |
| S081 | 2004-05-19 | 30-day Notice |
| S080 | 2003-12-08 | 30-day Notice |
| S079 | 2003-12-04 | Normal 180 Day Track No User Fee |
| S078 | 2003-09-12 | Special (immediate Track) |
| S077 | 2003-06-12 | 30-day Notice |
| S076 | 2003-02-06 | 30-day Notice |
| S075 | 2002-09-11 | 30-day Notice |
| S074 | 2002-06-03 | 30-day Notice |
| S073 | 2002-05-30 | 30-day Notice |
| S072 | 2002-05-20 | Normal 180 Day Track |
| S071 | 2002-04-10 | 30-day Notice |
| S070 | 2002-03-12 | 30-day Notice |
| S069 | 2002-03-05 | 30-day Notice |
| S068 | 2002-02-05 | Normal 180 Day Track |
| S067 | 2001-11-29 | Normal 180 Day Track |
| S066 | 2001-07-12 | Special (immediate Track) |
| S065 | 2001-06-12 | Normal 180 Day Track |
| S064 | 2001-05-30 | Normal 180 Day Track |
| S063 | 2001-04-30 | 30-day Notice |
| S062 | 2001-03-30 | Normal 180 Day Track |
| S061 | 2001-03-16 | 30-day Notice |
| S060 | 2001-02-06 | Normal 180 Day Track |
| S059 | 2000-12-06 | 30-day Notice |
| S058 | 2000-11-17 | 30-day Notice |
| S057 | 2000-11-07 | 30-day Notice |
| S056 | 2000-09-29 | Normal 180 Day Track |
| S055 | 2000-09-12 | Special (immediate Track) |
| S054 | 2000-09-08 | 30-day Notice |
| S053 | 2000-08-10 | 30-day Notice |
| S052 | 2000-06-30 | Special (immediate Track) |
| S051 | 2000-06-30 | 30-day Notice |
| S050 | 2000-06-29 | 30-day Notice |
| S049 | 2000-06-29 | Special (immediate Track) |
| S048 | 2000-06-19 | Real-time Process |
| S047 | 2000-06-15 | Special (immediate Track) |
| S046 | 2000-05-19 | 30-day Notice |
| S045 | 2000-05-18 | 30-day Notice |
| S044 | 2000-04-19 | 30-day Notice |
| S043 | 2000-03-17 | Special (immediate Track) |
| S042 | 2000-03-17 | 30-day Notice |
| S041 | 2000-03-16 | Special (immediate Track) |
| S040 | 2000-03-08 | 30-day Notice |
| S039 | 2000-03-06 | 30-day Notice |
| S038 | 2000-03-03 | Special (immediate Track) |
| S037 | 2000-02-04 | Special (immediate Track) |
| S036 | 2000-02-02 | Special (immediate Track) |
| S035 | 2000-01-21 | 30-day Notice |
| S034 | 2000-01-14 | Special (immediate Track) |
| S033 | 1999-12-17 | Normal 180 Day Track |
| S032 | 1999-11-23 | Normal 180 Day Track |
| S031 | 1999-10-20 | Normal 180 Day Track |
| S030 | 1999-10-20 | Special (immediate Track) |
| S029 | 1999-09-17 | Special (immediate Track) |
| S028 | 1999-06-23 | 30-day Notice |
| S027 | 1999-05-20 | Special (immediate Track) |
| S026 | 1998-08-20 | Normal 180 Day Track |
| S025 | 1998-08-14 | Normal 180 Day Track |
| S024 | 1998-08-11 | Real-time Process |
| S023 | 1998-01-30 | Normal 180 Day Track |
| S022 | 1997-11-07 | Normal 180 Day Track |
| S021 | 1997-08-20 | Normal 180 Day Track |
| S020 | 1996-09-26 | Normal 180 Day Track |
| S019 | 1996-07-03 | Normal 180 Day Track |
| S018 | 1996-06-20 | Normal 180 Day Track |
| S017 | 1996-04-12 | Normal 180 Day Track |
| S016 | 1996-03-22 | Normal 180 Day Track |
| S015 | 1996-01-17 | Normal 180 Day Track |
| S014 | 1996-01-11 | Normal 180 Day Track |
| S013 | ||
| S012 | 1995-06-30 | Normal 180 Day Track |
| S011 | 1995-04-06 | Normal 180 Day Track |
| S010 | 1995-03-07 | Normal 180 Day Track |
| S009 | 1994-12-08 | Normal 180 Day Track |
| S008 | 1994-05-17 | Normal 180 Day Track |
| S007 | ||
| S006 | 1993-12-07 | Normal 180 Day Track |
| S005 | 1993-11-05 | Normal 180 Day Track |
| S004 | 1993-10-25 | Normal 180 Day Track |
| S003 | 1993-07-23 | Normal 180 Day Track |
| S002 | 1993-07-23 | Normal 180 Day Track |
| S001 | 1993-07-16 | Normal 180 Day Track |