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.
Manufacturing process change to allow sterile product release based on demonstration of conformity to pre-defined sterilization parameters (parametric release) rather than release based on demonstrating no growth of biological indicators (conventional release).
| Device | CROSSSAIL, OPENSAIL, RX CHASSIS I & III AND VOYAGER CORONARY DILATATION CATHETERS |
| Classification Name | Stent, Coronary |
| Generic Name | Stent, Coronary |
| Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
| Date Received | 2004-12-21 |
| Decision Date | 2005-01-14 |
| PMA | P810046 |
| Supplement | S218 |
| Product Code | MAF |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process 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 |