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.
Approval for the scimed nc maxxum(tm) ptca catheter (20mm balloon length with balloon diameters of 2. 0mm, 2. 5-4. 0mm in 1/4mm increments and 4. 5mm, -5. 0mm in 1/2mm increments; and 9mm and 15mm lengths with balloon diameterrs of 2. 5-4. 0mm in 1/4mm increments and 4. 5mm - 5. 0mm) in 1/2mm increments. The nc maxxum(tm) ptca catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or byapss graft stenosis for th epurpose of improving myocardial perfusion. The nc maxuum(tm) ptca catheter (balloon models 2. 5-4. 0mm in diameter) is also indicated for the post-delivery expansion of balloon expandable stents.
| Device | SCIMED NC MAXXUM PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER |
| Classification Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | SCIMED LIFE SYSTEMS, INC. |
| Date Received | 1998-10-05 |
| Decision Date | 1999-04-08 |
| PMA | P860019 |
| Supplement | S150 |
| 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 |