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 acs rx comet vp(tm) coronary dilatation catheter. This device is indicated for balloon dilatation of the stenotic protion of a coronary artery or bypass graft stenosis for hte purpose of improving myocardial perfusion.
| Device | ACX RX COMET VP CORONARY DILATATION CATHETER |
| Classification Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
| Date Received | 1996-10-07 |
| Decision Date | 1997-02-04 |
| PMA | P810046 |
| Supplement | S169 |
| Product Code | LOX |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 Ynez Rd. temecula, CA 92591 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P810046 | Original 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 |