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 rotalink(tm) exchangeable catheter for the rotablator(r) rotational angioplasty system and is indicated for use in patients with coronary artery disease sho are candidates for coronary artery bypass graft (cabg) srugery and who meet one of the following criteria:single vessel atherosclerotic coronary artery disease with a stenosis that can be passed with a guide wire; multiple vessel coronary artery disease that in the physician's judgment does not pose undo risk to the patient; certain patients with previous ptca, and who have a restenosis of the native vessel; or native vessel atherosclerotic coronary artery disease that is less than 25 mm in length.
| Device | ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK(TM) |
| Classification Name | Catheter, Coronary, Atherectomy |
| Generic Name | Catheter, Coronary, Atherectomy |
| Applicant | Boston Scientific Corp. |
| Date Received | 1996-06-20 |
| Decision Date | 1997-02-13 |
| PMA | P900056 |
| Supplement | S018 |
| Product Code | MCX |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |