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 the alternate manufacturing facilities located at plexus corporation, bothell, washington for the manufacture of the rotablator(r) console and dynaglide(tm) foot pedal and boston scientific scimed ivus technology center, fremont, california fo rinspection functions.
| Device | ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM CONSOLE AND DYNAGLIDE(TM)FOOT PEDAL |
| Generic Name | Catheter, Coronary, Atherectomy |
| Applicant | Boston Scientific Corp. |
| Date Received | 2001-05-30 |
| Decision Date | 2001-09-07 |
| PMA | P900056 |
| Supplement | S064 |
| Product Code | MCX |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Express Gmp Supplement |
| 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 |