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.
Changes in the manufacturing process for the maverick monorail product line to include the use of a non-tapered production mandrel with blunt ends, and additional preventive measures to ensure that a thin wall condition does not occur in the inflation lumen, icluding the addition of a 100% vacuum decay test for both the maverick monorail and over-the-wire ptca catheters.
| Device | MAVERICK MONORAIL |
| Classification Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | SCIMED LIFE SYSTEMS, INC. |
| Date Received | 2001-03-13 |
| Decision Date | 2001-04-05 |
| PMA | P860019 |
| Supplement | S170 |
| 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 |