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.
Change to the methodology for sterilization dose audits.
Device | CORONARY DILATATION CATHETERS |
Classification Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
Date Received | 2010-09-17 |
Decision Date | 2010-10-15 |
PMA | P810046 |
Supplement | S240 |
Product Code | LOX |
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 |