SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Premarket Approval P810046

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

DeviceSIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE
Classification NameCatheters, Transluminal Coronary Angioplasty, Percutaneous
Generic NameCatheters, Transluminal Coronary Angioplasty, Percutaneous
ApplicantADVANCED CARDIOVASCULAR SYSTEMS, INC.
Date Received1981-09-11
Decision Date1982-03-03
Notice Date1982-03-26
PMAP810046
SupplementS
Product CodeLOX
Docket Number82M-0071
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 Ynez Rd. temecula, CA 92591

Supplemental Filings

Supplement NumberDateSupplement Type
P810046Original Filing
S240 2010-09-17 30-day Notice
S239
S238 2010-04-14 30-day Notice
S237 2010-04-02 Real-time Process
S236 2010-03-23 30-day Notice
S235
S234 2010-02-23 30-day Notice
S233
S232 2009-12-09 Real-time Process
S231 2009-05-01 30-day Notice
S230 2009-04-01 Normal 180 Day Track No User Fee
S229 2009-04-01 30-day Notice
S228 2009-03-09 135 Review Track For 30-day Notice
S227 2008-11-10 30-day Notice
S226 2008-02-11 Normal 180 Day Track
S225 2008-01-11 30-day Notice
S224 2007-08-21 30-day Notice
S223 2007-08-20 30-day Notice
S222 2007-06-04 Normal 180 Day Track
S221 2006-11-13 Normal 180 Day Track No User Fee
S220 2006-11-06 Normal 180 Day Track No User Fee
S219 2005-03-28 30-day Notice
S218 2004-12-21 30-day Notice
S217 2004-11-01 Normal 180 Day Track No User Fee
S216 2004-03-08 Normal 180 Day Track
S215 2004-01-26 Normal 180 Day Track
S214 2003-09-15 Normal 180 Day Track
S213 2002-09-27 30-day Notice
S212 2002-03-11 Normal 180 Day Track
S211
S210 2001-11-13 Normal 180 Day Track
S209 2001-05-17 Real-time Process
S208 2001-05-10 Real-time Process
S207 2001-05-07 30-day Notice
S206 2001-03-16 30-day Notice
S205 2000-12-19 Real-time Process
S204 2000-10-20 Real-time Process
S203 2000-10-17 Real-time Process
S202 2000-10-16 30-day Notice
S201 2000-02-28 Normal 180 Day Track
S200 2000-01-20 Real-time Process
S199 1999-10-08 30-day Notice
S198 1999-03-19 Normal 180 Day Track
S197 1999-02-09 Special (immediate Track)
S196 1998-12-22 Special (immediate Track)
S195 1998-12-21 Normal 180 Day Track
S194 1998-12-04 Normal 180 Day Track
S193 1998-08-11 Normal 180 Day Track
S192 1998-06-19 Normal 180 Day Track
S191
S190 1998-05-21 Real-time Process
S189 1998-04-30 Normal 180 Day Track
S188 1998-04-16 Normal 180 Day Track
S187 1998-01-26 Normal 180 Day Track
S186 1998-01-23 Normal 180 Day Track
S185 1998-01-20 Normal 180 Day Track
S184
S183 1997-12-18 Normal 180 Day Track
S182 1997-11-24 Normal 180 Day Track
S181 1997-08-18 Real-time Process
S180 1997-07-01 Special (immediate Track)
S179 1997-06-19 Normal 180 Day Track
S178
S177 1997-04-21 Normal 180 Day Track
S176 1997-03-14 Normal 180 Day Track
S175 1997-03-05 Normal 180 Day Track
S174 1997-02-25 Normal 180 Day Track
S173 1997-01-16 Normal 180 Day Track
S172 1996-12-23 Normal 180 Day Track
S171 1996-12-23 Normal 180 Day Track
S170 1996-11-25 Normal 180 Day Track
S169 1996-10-07 Normal 180 Day Track
S168 1996-08-22 Normal 180 Day Track
S167 1996-07-09 Normal 180 Day Track
S166 1996-06-27 Normal 180 Day Track
S165 1996-06-04 Normal 180 Day Track
S164
S163 1996-04-16 Normal 180 Day Track
S162 1996-04-16 Normal 180 Day Track
S161 1996-01-30 Normal 180 Day Track
S160 1995-11-22 Special (immediate Track)
S159 1995-10-23 Normal 180 Day Track
S158 1995-09-25 Normal 180 Day Track
S157 1995-09-14 Normal 180 Day Track
S156 1995-08-24 Normal 180 Day Track
S155 1995-04-11 30-Day Supplement
S154 1995-03-09 Normal 180 Day Track
S153 1994-10-04 Normal 180 Day Track
S152 1994-07-05 Normal 180 Day Track
S151 1994-06-06 Normal 180 Day Track
S150 1994-05-24 Normal 180 Day Track
S149 1994-05-16 Normal 180 Day Track
S148 1994-04-26 Normal 180 Day Track
S147 1993-11-24 Normal 180 Day Track
S146 1993-10-12 Normal 180 Day Track
S145 1993-09-13 Normal 180 Day Track
S144 1993-08-12 Normal 180 Day Track
S143 1993-08-13 Normal 180 Day Track
S142 1993-07-23 Normal 180 Day Track
S141
S140 1993-06-16 Normal 180 Day Track
S139 1992-12-16 Normal 180 Day Track
S138 1992-12-16 Normal 180 Day Track
S137 1992-11-13 Normal 180 Day Track
S136 1992-11-02 Normal 180 Day Track
S135 1992-10-22 Normal 180 Day Track
S134 1992-09-03 Normal 180 Day Track
S133 1992-09-03 Normal 180 Day Track
S132 1992-08-27 Normal 180 Day Track
S131 1992-08-19 Normal 180 Day Track
S130 1992-08-10 Normal 180 Day Track
S129 1992-07-24 Normal 180 Day Track
S128
S127 1992-06-16 Normal 180 Day Track
S126 1992-06-09 Normal 180 Day Track
S125 1992-06-01 Normal 180 Day Track
S124 1992-04-23 Normal 180 Day Track
S123 1992-03-06 Normal 180 Day Track
S122 1992-03-05 Normal 180 Day Track
S121 1992-03-02 Normal 180 Day Track
S120
S119 1992-01-29 Normal 180 Day Track
S118 1991-12-23 Normal 180 Day Track
S117 1991-12-23 Normal 180 Day Track
S116 1991-12-20 Normal 180 Day Track
S115 1991-11-07 Special (immediate Track)
S114 1991-11-06 Normal 180 Day Track
S113 1991-10-18 Normal 180 Day Track
S112 1991-09-17 Normal 180 Day Track
S111 1991-09-19 Normal 180 Day Track
S110 1991-09-17 Normal 180 Day Track
S109 1991-08-08 Normal 180 Day Track
S108 1991-07-18 Normal 180 Day Track
S107 1991-07-17 Normal 180 Day Track
S106 1991-06-17 Normal 180 Day Track
S105 1991-06-12 Normal 180 Day Track
S104 1991-05-30 Normal 180 Day Track
S103 1991-05-23 Normal 180 Day Track
S102 1991-05-20 Normal 180 Day Track
S101 1990-10-19 Normal 180 Day Track
S100 1991-03-05 Normal 180 Day Track
S099 1991-01-07 Normal 180 Day Track
S098 1990-12-04 Normal 180 Day Track
S097 1990-11-21 Normal 180 Day Track
S096 1990-11-20 Normal 180 Day Track
S095 1990-11-13 Normal 180 Day Track
S094 1990-10-09 Normal 180 Day Track
S093 1990-10-02 Normal 180 Day Track
S092
S091 1990-09-21 Normal 180 Day Track
S090
S089 1990-06-15 Normal 180 Day Track
S088 1990-08-24 Normal 180 Day Track
S087 1990-08-20 Normal 180 Day Track
S086 1990-08-17 Normal 180 Day Track
S085 1990-08-17 Normal 180 Day Track
S084 1990-07-27 Normal 180 Day Track
S083 1990-07-10 Normal 180 Day Track
S082
S081 1990-07-05 Normal 180 Day Track
S080 1990-06-26 Normal 180 Day Track
S079 1990-06-26 Normal 180 Day Track
S078 1990-06-15 Normal 180 Day Track
S077 1990-06-15 Normal 180 Day Track
S076 1990-05-29 Normal 180 Day Track
S075 1990-05-25 Normal 180 Day Track
S074 1990-05-15 Special (immediate Track)
S073 1990-05-15 Normal 180 Day Track
S072 1990-05-03 Normal 180 Day Track
S071 1990-03-14 Normal 180 Day Track
S070 1990-01-22 Normal 180 Day Track
S069 1989-12-21 Normal 180 Day Track
S068 1989-12-21 Normal 180 Day Track
S067 1989-12-22 Normal 180 Day Track
S066 1989-10-31 Normal 180 Day Track
S065 1989-12-01 Normal 180 Day Track
S064 1989-09-29 Normal 180 Day Track
S063 1989-09-05 Normal 180 Day Track
S062 1989-08-08 Normal 180 Day Track
S061 1989-06-21 Normal 180 Day Track
S060 1989-06-21 Normal 180 Day Track
S059 1989-07-25 Normal 180 Day Track
S058 1989-07-24 Normal 180 Day Track
S057 1989-05-15 Normal 180 Day Track
S056
S055 1989-04-27 Normal 180 Day Track
S054 1989-02-02 Normal 180 Day Track
S053 1989-02-02 Normal 180 Day Track
S052 1988-11-18 Normal 180 Day Track
S051 1988-10-03 Normal 180 Day Track
S050 1988-09-26 Normal 180 Day Track
S049 1988-08-11 Normal 180 Day Track
S048 1988-05-06 Normal 180 Day Track
S047 1988-05-03 Panel Track
S046 1988-05-03 Normal 180 Day Track
S045 1988-04-01 Normal 180 Day Track
S044 1988-01-28 Normal 180 Day Track
S043 1988-01-26 Normal 180 Day Track
S042 1987-12-22 Special (immediate Track)
S041 1987-12-09 Normal 180 Day Track
S040 1987-10-26 Normal 180 Day Track
S039 1987-10-03 Normal 180 Day Track
S038 1987-09-08 Normal 180 Day Track
S037
S036 1987-07-31 Normal 180 Day Track
S035 1987-07-27 Normal 180 Day Track
S034 1987-06-19 Normal 180 Day Track
S033 1987-06-03 Normal 180 Day Track
S032 1987-05-26 Normal 180 Day Track
S031 1987-04-29 Normal 180 Day Track
S030
S029 1987-03-03 Normal 180 Day Track
S028
S027 1986-09-12 Normal 180 Day Track
S026 1986-08-04 Normal 180 Day Track
S025 1986-07-14 Normal 180 Day Track
S024 1986-06-11 Normal 180 Day Track
S023 1986-06-02 Normal 180 Day Track
S022
S021 1986-01-14
S020 1985-10-25
S019 1985-10-18
S018 1985-10-15
S017 1985-10-03
S016 1985-09-10
S015 1985-08-01
S014 1985-07-22
S013
S012 1984-12-19
S011 1984-04-27
S010 1984-01-19
S009 1983-11-14
S008 1983-06-21
S007 1983-06-07
S006 1983-05-31
S005
S004 1983-05-02
S003 1983-04-22
S002 1982-11-17
S001 1982-03-22
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