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 voyager nc coronary dilatation catheter. The device, as modified, will be marketed under the trade name voyager nc coronary dilatation catheter and is indicated for: 1) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis of the purpose of improving myocardial perfusion; 2) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction; 3) balloon dilatation of a stent after implantation.
| Device | VOYAGER NC CORONARY DILATATION CATHETER |
| Classification Name | Stent, Coronary |
| Generic Name | Stent, Coronary |
| Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
| Date Received | 2008-02-11 |
| Decision Date | 2008-08-21 |
| PMA | P810046 |
| Supplement | S226 |
| Product Code | MAF |
| 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 |