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 a manufacturing site located at guidant ireland, tippery, ireland.
Device | RX VOYAGER CORONARY DILATATION CATHETER |
Classification Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
Date Received | 2004-11-01 |
Decision Date | 2005-11-22 |
PMA | P810046 |
Supplement | S217 |
Product Code | LOX |
Advisory Committee | Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
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 |