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 to provide the rotablator(r) rotalink system to the user in a pre-connected configuration. The device, as modified, will be marketed under the trade name rotoblator(r) rotalink plus(tm) rotational angioplasty system and is indicated as a means of providng percutaneous rotational coronary angioplasty, as a sole therapy or with adjunctive balloon angioplasty, in patients with coronary artery disease who are candidates for coronary artery bypass graft surgery and who meet one of the following selection criteria: 1) single vessel atherosclerotic coronary artery disease with a stenosis that can be passed with a guide wire; 2) multiple vessel coronary artery disease that in the physician's judgment does not pose undue risk to the patient; 3) certain patients who have had prior percutaneous transluminal coronary angioplasty (ptca), and who have a restenosis of the native vessel; or 4) native vessel atherosclerotic coronary artery disease that is less than 25mm in length.
| Device | ROTABLATOR ROTALINK PLUS ROTATIONAL ANGIOPLASTY SYSTEM |
| Generic Name | Catheter, Coronary, Atherectomy |
| Applicant | Boston Scientific Corp. |
| Date Received | 1998-08-11 |
| Decision Date | 1998-09-02 |
| PMA | P900056 |
| Supplement | S024 |
| Product Code | MCX |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| 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 |