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.
Alternate distal welding process.
Device | APEX PTCA BALLOON DILATATION CATHETER |
Classification Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
Applicant | SCIMED LIFE SYSTEMS, INC. |
Date Received | 2009-08-13 |
Decision Date | 2009-09-08 |
PMA | P860019 |
Supplement | S238 |
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 |