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.
Removal of a redundant verification step.
| Device | APEX MONORAIL & OVER-THE-WIRE PTCA CATHETERS |
| Classification Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | SCIMED LIFE SYSTEMS, INC. |
| Date Received | 2009-05-01 |
| Decision Date | 2009-05-08 |
| PMA | P860019 |
| Supplement | S236 |
| 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 |