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 additional balloon sizes and an additional indication for use for the acs rx solaris(tm) coronary dilatation catheter. The device as indicated for: a)balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. B) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction. C) balloon dilatation of the acs multi-link duet(tm) stent after implantation. This indication applies to the following balloon sizes and stent lengths: ballon size:3. 0-4. 0mmx9mm stent length: 13mm 3. 0-4. 0mmx15mm 18mm 3. 0-4. 0mmx20mm 23mm 3. 0-4. 0mmx25mm 28mm
| Device | ACS RX SOLARIS CORONARY DILATATION CATHETER |
| Classification Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
| Date Received | 1998-12-04 |
| Decision Date | 1999-04-14 |
| PMA | P810046 |
| Supplement | S194 |
| 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 |