Rotablator Rotational Atherectomy System and ROTAPRO Rotational Atherectomy System

FDA Premarket Approval P900056 S186

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.

Pre-market Approval Supplement Details

Modifications to quality control inspection process

DeviceRotablator Rotational Atherectomy System and ROTAPRO Rotational Atherectomy System
Generic NameCatheter, Coronary, Atherectomy
ApplicantBoston Scientific Corp.
Date Received2020-06-17
Decision Date2020-07-16
PMAP900056
SupplementS186
Product CodeMCX 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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
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
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08714729999584 P900056 181
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08714729999614 P900056 181
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08714729999591 P900056 181
08714729999584 P900056 181
08714729999607 P900056 181

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