ROTABLATOR(R)

Catheter, Coronary, Atherectomy

FDA Premarket Approval P900056

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

DeviceROTABLATOR(R)
Classification NameCatheter, Coronary, Atherectomy
Generic NameCatheter, Coronary, Atherectomy
ApplicantBoston Scientific Corp.
Date Received1990-08-28
Decision Date1993-05-28
Notice Date1993-07-16
PMAP900056
SupplementS
Product CodeMCX
Docket Number93M-0208
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address Boston Scientific Corp. two Scimed Place maple Grove, MN 55311-1566

Supplemental Filings

Supplement NumberDateSupplement Type
P900056Original 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

NIH GUDID Devices

Device IDPMASupp
08714729317739 P900056 000
08714729316473 P900056 000
08714729316442 P900056 000
08714729316466 P900056 000
08714729316411 P900056 000
08714729228424 P900056 000
08714729228394 P900056 000
08714729228370 P900056 000
08714729228363 P900056 000
08714729185864 P900056 000
08714729126881 P900056 000
08714729185796 P900056 000
08714729185802 P900056 000
08714729185826 P900056 000
08714729185819 P900056 000
08714729185840 P900056 000
08714729185857 P900056 000
08714729837619 P900056 123
08714729893417 P900056 166
08714729893356 P900056 166
08714729893363 P900056 166
08714729893370 P900056 166
08714729975106 P900056 166
08714729975090 P900056 166
08714729975083 P900056 166
08714729975076 P900056 166
08714729893431 P900056 166
08714729893424 P900056 166
08714729893400 P900056 166
08714729893394 P900056 166
08714729893387 P900056 166
08714729999607 P900056 181
08714729999584 P900056 181
08714729999591 P900056 181
08714729999577 P900056 181
08714729999560 P900056 181
08714729999621 P900056 181
08714729999638 P900056 181
08714729999614 P900056 181
08714729996262 P900056 183
08714729996248 P900056 183
00191506005566 P900056 201
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