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 in the manufacturing process which involved the use of an alternate biological indicator (bi) with a shorter labeled incubation time of four (4) hours for use in monitoring the eo sterilization cycles and sterilization process validation.
| Device | PTCA/PERFUSION CATHETERS |
| Classification Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | SCIMED LIFE SYSTEMS, INC. |
| Date Received | 2003-12-08 |
| Decision Date | 2004-01-07 |
| PMA | P860019 |
| Supplement | S199 |
| 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 | SCIMED LIFE SYSTEMS, INC. one Scimed Place maple Grove, MN 55311-1566 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P860019 | Original Filing | |
| S264 | 2010-10-07 | 135 Review Track For 30-day Notice |
| S263 | 2010-08-13 | 30-day Notice |
| S262 | ||
| S261 | 2010-08-09 | 30-day Notice |
| S260 | 2010-08-02 | 30-day Notice |
| S259 | 2010-07-14 | 30-day Notice |
| S258 | 2010-06-29 | 30-day Notice |
| S257 | ||
| S256 | 2010-05-25 | 30-day Notice |
| S255 | 2010-04-27 | 30-day Notice |
| S254 | ||
| S253 | 2010-03-22 | 30-day Notice |
| S252 | 2010-03-08 | Real-time Process |
| S251 | 2010-03-08 | 30-day Notice |
| S250 | 2010-02-01 | 30-day Notice |
| S249 | 2010-01-26 | 30-day Notice |
| S248 | 2010-01-26 | 30-day Notice |
| S247 | 2010-01-13 | 30-day Notice |
| S246 | 2009-12-03 | 30-day Notice |
| S245 | 2009-11-05 | 30-day Notice |
| S244 | 2009-11-05 | 30-day Notice |
| S243 | 2009-10-30 | 30-day Notice |
| S242 | 2009-10-01 | Real-time Process |
| S241 | 2009-09-04 | Real-time Process |
| S240 | 2009-08-31 | 30-day Notice |
| S239 | ||
| S238 | 2009-08-13 | 30-day Notice |
| S237 | 2009-08-05 | 135 Review Track For 30-day Notice |
| S236 | 2009-05-01 | 30-day Notice |
| S235 | 2009-04-17 | 30-day Notice |
| S234 | 2009-04-10 | 135 Review Track For 30-day Notice |
| S233 | 2009-03-30 | 30-day Notice |
| S232 | 2009-03-30 | 135 Review Track For 30-day Notice |
| S231 | 2009-01-16 | 30-day Notice |
| S230 | 2008-10-30 | Real-time Process |
| S229 | 2008-10-08 | 30-day Notice |
| S228 | 2008-08-28 | 30-day Notice |
| S227 | 2008-08-12 | Real-time Process |
| S226 | 2008-05-19 | 30-day Notice |
| S225 | 2008-05-06 | Real-time Process |
| S224 | 2008-03-31 | 30-day Notice |
| S223 | 2008-03-31 | 30-day Notice |
| S222 | 2008-01-28 | 30-day Notice |
| S221 | 2007-08-23 | 135 Review Track For 30-day Notice |
| S220 | 2007-04-18 | 30-day Notice |
| S219 | 2007-02-01 | 30-day Notice |
| S218 | ||
| S217 | 2006-12-07 | 135 Review Track For 30-day Notice |
| S216 | 2006-11-30 | 135 Review Track For 30-day Notice |
| S215 | 2006-09-21 | 30-day Notice |
| S214 | 2006-09-20 | 30-day Notice |
| S213 | 2006-09-13 | 30-day Notice |
| S212 | 2006-09-13 | 30-day Notice |
| S211 | 2006-05-26 | 30-day Notice |
| S210 | 2006-05-23 | 30-day Notice |
| S209 | 2006-05-09 | 30-day Notice |
| S208 | 2006-04-24 | Normal 180 Day Track |
| S207 | 2006-02-02 | 30-day Notice |
| S206 | 2005-12-14 | 30-day Notice |
| S205 | 2005-07-25 | Real-time Process |
| S204 | ||
| S203 | 2005-03-14 | Normal 180 Day Track No User Fee |
| S202 | 2005-02-02 | Special (immediate Track) |
| S201 | 2004-11-01 | 135 Review Track For 30-day Notice |
| S200 | 2004-05-12 | 30-day Notice |
| S199 | 2003-12-08 | 30-day Notice |
| S198 | 2003-08-15 | 30-day Notice |
| S197 | 2003-08-11 | 30-day Notice |
| S196 | 2003-06-27 | 30-day Notice |
| S195 | 2003-06-04 | 135 Review Track For 30-day Notice |
| S194 | 2002-12-24 | Normal 180 Day Track |
| S193 | ||
| S192 | 2002-11-25 | Real-time Process |
| S191 | 2002-11-14 | Normal 180 Day Track |
| S190 | 2002-10-24 | Normal 180 Day Track |
| S189 | 2002-10-11 | Special (immediate Track) |
| S188 | 2002-10-07 | Normal 180 Day Track |
| S187 | 2002-09-23 | 30-day Notice |
| S186 | 2002-07-17 | 135 Review Track For 30-day Notice |
| S185 | 2002-06-05 | Special (immediate Track) |
| S184 | 2002-05-29 | 30-day Notice |
| S183 | 2002-05-02 | Normal 180 Day Track |
| S182 | 2002-04-16 | Normal 180 Day Track |
| S181 | 2002-04-10 | 30-day Notice |
| S180 | 2002-04-04 | Normal 180 Day Track |
| S179 | 2002-02-07 | Normal 180 Day Track |
| S178 | 2002-01-22 | 30-day Notice |
| S177 | 2001-10-05 | Special (immediate Track) |
| S176 | 2001-08-06 | Normal 180 Day Track |
| S175 | 2001-07-12 | Special (immediate Track) |
| S174 | 2001-05-07 | Real-time Process |
| S173 | 2001-04-13 | Real-time Process |
| S172 | 2001-04-11 | 30-day Notice |
| S171 | 2001-04-04 | 30-day Notice |
| S170 | 2001-03-13 | 30-day Notice |
| S169 | 2001-02-27 | 30-day Notice |
| S168 | 2000-11-29 | 135 Review Track For 30-day Notice |
| S167 | 2000-11-17 | Real-time Process |
| S166 | 2000-11-13 | 30-day Notice |
| S165 | ||
| S164 | 2000-06-21 | Normal 180 Day Track |
| S163 | 2000-05-24 | 30-day Notice |
| S162 | 2000-04-12 | Normal 180 Day Track |
| S161 | 2000-04-06 | 30-day Notice |
| S160 | 2000-03-31 | Normal 180 Day Track |
| S159 | 2000-02-29 | Special (immediate Track) |
| S158 | 1999-11-10 | Normal 180 Day Track |
| S157 | 1999-10-06 | 30-day Notice |
| S156 | 1999-08-03 | Normal 180 Day Track |
| S155 | 1999-03-16 | Real-time Process |
| S154 | 1999-03-15 | Real-time Process |
| S153 | 1999-02-01 | Normal 180 Day Track |
| S152 | 1999-01-25 | Real-time Process |
| S151 | 1998-12-14 | Real-time Process |
| S150 | 1998-10-05 | Normal 180 Day Track |
| S149 | 1998-08-21 | Normal 180 Day Track |
| S148 | ||
| S147 | 1998-06-30 | Special (immediate Track) |
| S146 | 1998-06-30 | Real-time Process |
| S145 | 1998-06-03 | Real-time Process |
| S144 | 1998-04-27 | Normal 180 Day Track |
| S143 | 1998-04-14 | Normal 180 Day Track |
| S142 | 1998-04-06 | Real-time Process |
| S141 | 1998-02-18 | Normal 180 Day Track |
| S140 | 1998-02-18 | Normal 180 Day Track |
| S139 | ||
| S138 | 1998-02-25 | Real-time Process |
| S137 | 1998-01-14 | Normal 180 Day Track |
| S136 | 1997-11-25 | Normal 180 Day Track |
| S135 | 1997-11-24 | Real-time Process |
| S134 | 1997-10-20 | Real-time Process |
| S133 | 1997-10-14 | Normal 180 Day Track |
| S132 | 1997-11-03 | Real-time Process |
| S131 | 1997-10-03 | Normal 180 Day Track |
| S130 | 1997-09-24 | Real-time Process |
| S129 | 1997-09-25 | Normal 180 Day Track |
| S128 | 1997-07-21 | Normal 180 Day Track |
| S127 | ||
| S126 | 1997-07-16 | Real-time Process |
| S125 | 1997-06-30 | Real-time Process |
| S124 | 1997-06-30 | Real-time Process |
| S123 | 1997-06-16 | Real-time Process |
| S122 | 1997-05-09 | Special (immediate Track) |
| S121 | 1997-03-14 | Normal 180 Day Track |
| S120 | 1997-02-27 | Normal 180 Day Track |
| S119 | 1996-11-22 | Normal 180 Day Track |
| S118 | 1996-09-19 | Normal 180 Day Track |
| S117 | 1996-08-06 | Normal 180 Day Track |
| S116 | 1996-07-15 | Normal 180 Day Track |
| S115 | 1996-07-11 | Normal 180 Day Track |
| S114 | 1996-06-17 | Normal 180 Day Track |
| S113 | 1996-05-02 | Normal 180 Day Track |
| S112 | 1996-04-29 | Normal 180 Day Track |
| S111 | 1996-04-16 | Normal 180 Day Track |
| S110 | 1996-01-19 | Normal 180 Day Track |
| S109 | 1995-12-22 | Normal 180 Day Track |
| S108 | 1995-11-01 | Normal 180 Day Track |
| S107 | 1995-07-31 | Normal 180 Day Track |
| S106 | 1995-08-17 | Normal 180 Day Track |
| S105 | 1995-07-31 | Normal 180 Day Track |
| S104 | 1995-07-21 | Normal 180 Day Track |
| S103 | 1995-07-12 | Normal 180 Day Track |
| S102 | 1995-07-07 | Normal 180 Day Track |
| S101 | 1995-07-05 | Normal 180 Day Track |
| S100 | 1995-06-12 | Normal 180 Day Track |
| S099 | 1995-04-11 | 30-Day Supplement |
| S098 | 1995-02-21 | Normal 180 Day Track |
| S097 | 1994-12-29 | Normal 180 Day Track |
| S096 | 1994-10-21 | Normal 180 Day Track |
| S095 | 1994-10-19 | Normal 180 Day Track |
| S094 | 1994-10-05 | Normal 180 Day Track |
| S093 | 1994-09-06 | Normal 180 Day Track |
| S092 | ||
| S091 | 1994-09-01 | Normal 180 Day Track |
| S090 | 1994-08-17 | Normal 180 Day Track |
| S089 | 1994-08-01 | Normal 180 Day Track |
| S088 | 1994-07-25 | Normal 180 Day Track |
| S087 | 1994-07-05 | Normal 180 Day Track |
| S086 | 1994-06-13 | Normal 180 Day Track |
| S085 | 1994-05-12 | Normal 180 Day Track |
| S084 | 1994-05-02 | Normal 180 Day Track |
| S083 | 1994-04-13 | Normal 180 Day Track |
| S082 | 1994-01-07 | Normal 180 Day Track |
| S081 | 1993-11-05 | Normal 180 Day Track |
| S080 | 1993-11-01 | Normal 180 Day Track |
| S079 | 1993-10-18 | Normal 180 Day Track |
| S078 | ||
| S077 | 1993-08-23 | Normal 180 Day Track |
| S076 | 1993-08-05 | Normal 180 Day Track |
| S075 | 1993-07-29 | Normal 180 Day Track |
| S074 | 1993-07-16 | Normal 180 Day Track |
| S073 | 1991-07-29 | Normal 180 Day Track |
| S072 | 1993-06-03 | Normal 180 Day Track |
| S071 | 1993-03-08 | Normal 180 Day Track |
| S070 | 1993-02-11 | Normal 180 Day Track |
| S069 | 1993-01-14 | Normal 180 Day Track |
| S068 | 1993-01-08 | Normal 180 Day Track |
| S067 | 1992-11-09 | Normal 180 Day Track |
| S066 | 1992-11-02 | Normal 180 Day Track |
| S065 | 1992-10-20 | Special (immediate Track) |
| S064 | 1992-10-07 | Normal 180 Day Track |
| S063 | 1992-09-02 | Normal 180 Day Track |
| S062 | ||
| S061 | 1992-08-07 | Normal 180 Day Track |
| S060 | 1992-04-30 | Normal 180 Day Track |
| S059 | 1992-04-29 | Normal 180 Day Track |
| S058 | 1992-03-30 | Normal 180 Day Track |
| S057 | ||
| S056 | 1992-02-14 | Normal 180 Day Track |
| S055 | 1992-02-11 | Normal 180 Day Track |
| S054 | 1992-01-30 | Normal 180 Day Track |
| S053 | 1992-01-06 | Normal 180 Day Track |
| S052 | 1991-12-23 | Normal 180 Day Track |
| S051 | 1991-12-09 | Normal 180 Day Track |
| S050 | 1991-11-19 | Normal 180 Day Track |
| S049 | ||
| S048 | 1991-10-01 | Normal 180 Day Track |
| S047 | 1991-06-24 | Normal 180 Day Track |
| S046 | 1991-06-18 | Normal 180 Day Track |
| S045 | 1991-06-17 | Normal 180 Day Track |
| S044 | 1991-05-31 | Normal 180 Day Track |
| S043 | 1991-05-24 | Normal 180 Day Track |
| S042 | 1991-05-16 | Normal 180 Day Track |
| S041 | 1991-04-22 | Normal 180 Day Track |
| S040 | 1991-02-28 | Normal 180 Day Track |
| S039 | 1991-02-19 | Normal 180 Day Track |
| S038 | 1990-12-31 | Special (immediate Track) |
| S037 | 1990-12-10 | Special (immediate Track) |
| S036 | ||
| S035 | 1990-10-15 | Normal 180 Day Track |
| S034 | 1990-10-11 | Normal 180 Day Track |
| S033 | 1990-10-11 | Normal 180 Day Track |
| S032 | 1990-08-16 | Special (immediate Track) |
| S031 | 1990-08-07 | Normal 180 Day Track |
| S030 | 1990-08-07 | Normal 180 Day Track |
| S029 | 1990-05-22 | Normal 180 Day Track |
| S028 | 1990-03-16 | Normal 180 Day Track |
| S027 | 1990-02-07 | Normal 180 Day Track |
| S026 | 1990-02-05 | Normal 180 Day Track |
| S025 | 1990-01-19 | Normal 180 Day Track |
| S024 | 1989-08-16 | Normal 180 Day Track |
| S023 | 1989-08-14 | Normal 180 Day Track |
| S022 | 1989-08-11 | Normal 180 Day Track |
| S021 | 1989-07-20 | Normal 180 Day Track |
| S020 | 1989-06-02 | Normal 180 Day Track |
| S019 | 1989-01-30 | Normal 180 Day Track |
| S018 | 1988-10-11 | Normal 180 Day Track |
| S017 | 1988-09-26 | Normal 180 Day Track |
| S016 | 1988-09-26 | Normal 180 Day Track |
| S015 | 1988-08-25 | Normal 180 Day Track |
| S014 | 1988-08-11 | Normal 180 Day Track |
| S013 | 1988-08-01 | Normal 180 Day Track |
| S012 | 1988-07-13 | Normal 180 Day Track |
| S011 | 1988-06-09 | Special (immediate Track) |
| S010 | 1988-06-08 | Normal 180 Day Track |
| S009 | 1988-04-04 | Normal 180 Day Track |
| S008 | 1988-03-08 | Special (immediate Track) |
| S007 | 1988-02-16 | Normal 180 Day Track |
| S006 | 1987-12-17 | Normal 180 Day Track |
| S005 | 1987-10-28 | Normal 180 Day Track |
| S004 | 1987-09-24 | Normal 180 Day Track |
| S003 | 1987-08-25 | Normal 180 Day Track |
| S002 | 1987-05-15 | Normal 180 Day Track |
| S001 | 1987-02-04 | Normal 180 Day Track |