Device | SCIMED(R) GRAFT ACE(TM) PTCA CATHETER |
Classification Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
Applicant | SCIMED LIFE SYSTEMS, INC. |
Date Received | 1992-03-30 |
Decision Date | 1993-02-05 |
PMA | P860019 |
Supplement | S058 |
Product Code | LOX |
Advisory Committee | Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/components/specifications/material |
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 |