SCIMED ACE(TM) & EXPRESS(TM) PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Premarket Approval P860019 S044

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.

Pre-market Approval Supplement Details

DeviceSCIMED ACE(TM) & EXPRESS(TM) PTCA CATHETERS
Classification NameCatheters, Transluminal Coronary Angioplasty, Percutaneous
Generic NameCatheters, Transluminal Coronary Angioplasty, Percutaneous
ApplicantSCIMED LIFE SYSTEMS, INC.
Date Received1991-05-31
Decision Date1991-11-19
PMAP860019
SupplementS044
Product CodeLOX
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address SCIMED LIFE SYSTEMS, INC. one Scimed Place maple Grove, MN 55311-1566

Supplemental Filings

Supplement NumberDateSupplement Type
P860019Original 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

NIH GUDID Devices

Device IDPMASupp
08714729224419 P860019 162
08714729302797 P860019 162
08714729302780 P860019 162
08714729302773 P860019 162
08714729302766 P860019 162
08714729260479 P860019 162
08714729260462 P860019 162
08714729260455 P860019 162
08714729260448 P860019 162
08714729260431 P860019 162
08714729260424 P860019 162
08714729260417 P860019 162
08714729260400 P860019 162
08714729302803 P860019 162
08714729303558 P860019 162
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08714729312802 P860019 162
08714729312796 P860019 162
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08714729303619 P860019 162
08714729303602 P860019 162
08714729303596 P860019 162
08714729303589 P860019 162
08714729303572 P860019 162
08714729303565 P860019 162
08714729260394 P860019 162
08714729260363 P860019 162
08714729312734 P860019 162
08714729260196 P860019 162
08714729260189 P860019 162
08714729260172 P860019 162
08714729224617 P860019 162
08714729224594 P860019 162
08714729224563 P860019 162
08714729224433 P860019 162
08714729224532 P860019 162
08714729224525 P860019 162
08714729224471 P860019 162
08714729224464 P860019 162
08714729224457 P860019 162
08714729260202 P860019 162
08714729260219 P860019 162
08714729260356 P860019 162
08714729260349 P860019 162
08714729260332 P860019 162
08714729260325 P860019 162
08714729260318 P860019 162
08714729260301 P860019 162
08714729260295 P860019 162
08714729260288 P860019 162
08714729260264 P860019 162
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08714729260240 P860019 162
08714729260233 P860019 162
08714729260226 P860019 162
08714729370239 P860019 179
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08714729393313 P860019 182
08714729393320 P860019 182
08714729393337 P860019 182
08714729393467 P860019 182
08714729392521 P860019 182
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08714729392675 P860019 182
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08714729392699 P860019 182
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08714729392712 P860019 182
08714729392729 P860019 182
08714729392736 P860019 182
08714729392644 P860019 182
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08714729392620 P860019 182
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08714729393535 P860019 182
08714729393528 P860019 182
08714729393511 P860019 182
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08714729393498 P860019 182
08714729393481 P860019 182
08714729475637 P860019 208
08714729475613 P860019 208
08714729475606 P860019 208
08714729475590 P860019 208
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08714729475651 P860019 208
08714729475668 P860019 208
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08714729475699 P860019 208
08714729475705 P860019 208
08714729475712 P860019 208
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08714729475415 P860019 208
08714729475422 P860019 208
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08714729475453 P860019 208
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08714729475491 P860019 208
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08714729475514 P860019 208
08714729475521 P860019 208
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08714729475545 P860019 208
08714729475408 P860019 208
08714729475736 P860019 208
08714729475743 P860019 208
08714729475927 P860019 208
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08714729475958 P860019 208
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08714729475996 P860019 208
08714729476009 P860019 208
08714729476016 P860019 208
08714729758457 P860019 208
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08714729785866 P860019 241
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08714729785903 P860019 241
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08714729785583 P860019 241
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08714729785545 P860019 241
08714729785538 P860019 241
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08714729786085 P860019 241
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