ACS(R) HARTZLER EXCEL CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Premarket Approval P810046 S077

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

DeviceACS(R) HARTZLER EXCEL CORONARY DILATATION CATHETER
Classification NameCatheters, Transluminal Coronary Angioplasty, Percutaneous
Generic NameCatheters, Transluminal Coronary Angioplasty, Percutaneous
ApplicantADVANCED CARDIOVASCULAR SYSTEMS, INC.
Date Received1990-06-15
Decision Date1990-12-18
PMAP810046
SupplementS077
Product CodeLOX
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 Ynez Rd. temecula, CA 92591

Supplemental Filings

Supplement NumberDateSupplement Type
P810046Original Filing
S240 2010-09-17 30-day Notice
S239
S238 2010-04-14 30-day Notice
S237 2010-04-02 Real-time Process
S236 2010-03-23 30-day Notice
S235
S234 2010-02-23 30-day Notice
S233
S232 2009-12-09 Real-time Process
S231 2009-05-01 30-day Notice
S230 2009-04-01 Normal 180 Day Track No User Fee
S229 2009-04-01 30-day Notice
S228 2009-03-09 135 Review Track For 30-day Notice
S227 2008-11-10 30-day Notice
S226 2008-02-11 Normal 180 Day Track
S225 2008-01-11 30-day Notice
S224 2007-08-21 30-day Notice
S223 2007-08-20 30-day Notice
S222 2007-06-04 Normal 180 Day Track
S221 2006-11-13 Normal 180 Day Track No User Fee
S220 2006-11-06 Normal 180 Day Track No User Fee
S219 2005-03-28 30-day Notice
S218 2004-12-21 30-day Notice
S217 2004-11-01 Normal 180 Day Track No User Fee
S216 2004-03-08 Normal 180 Day Track
S215 2004-01-26 Normal 180 Day Track
S214 2003-09-15 Normal 180 Day Track
S213 2002-09-27 30-day Notice
S212 2002-03-11 Normal 180 Day Track
S211
S210 2001-11-13 Normal 180 Day Track
S209 2001-05-17 Real-time Process
S208 2001-05-10 Real-time Process
S207 2001-05-07 30-day Notice
S206 2001-03-16 30-day Notice
S205 2000-12-19 Real-time Process
S204 2000-10-20 Real-time Process
S203 2000-10-17 Real-time Process
S202 2000-10-16 30-day Notice
S201 2000-02-28 Normal 180 Day Track
S200 2000-01-20 Real-time Process
S199 1999-10-08 30-day Notice
S198 1999-03-19 Normal 180 Day Track
S197 1999-02-09 Special (immediate Track)
S196 1998-12-22 Special (immediate Track)
S195 1998-12-21 Normal 180 Day Track
S194 1998-12-04 Normal 180 Day Track
S193 1998-08-11 Normal 180 Day Track
S192 1998-06-19 Normal 180 Day Track
S191
S190 1998-05-21 Real-time Process
S189 1998-04-30 Normal 180 Day Track
S188 1998-04-16 Normal 180 Day Track
S187 1998-01-26 Normal 180 Day Track
S186 1998-01-23 Normal 180 Day Track
S185 1998-01-20 Normal 180 Day Track
S184
S183 1997-12-18 Normal 180 Day Track
S182 1997-11-24 Normal 180 Day Track
S181 1997-08-18 Real-time Process
S180 1997-07-01 Special (immediate Track)
S179 1997-06-19 Normal 180 Day Track
S178
S177 1997-04-21 Normal 180 Day Track
S176 1997-03-14 Normal 180 Day Track
S175 1997-03-05 Normal 180 Day Track
S174 1997-02-25 Normal 180 Day Track
S173 1997-01-16 Normal 180 Day Track
S172 1996-12-23 Normal 180 Day Track
S171 1996-12-23 Normal 180 Day Track
S170 1996-11-25 Normal 180 Day Track
S169 1996-10-07 Normal 180 Day Track
S168 1996-08-22 Normal 180 Day Track
S167 1996-07-09 Normal 180 Day Track
S166 1996-06-27 Normal 180 Day Track
S165 1996-06-04 Normal 180 Day Track
S164
S163 1996-04-16 Normal 180 Day Track
S162 1996-04-16 Normal 180 Day Track
S161 1996-01-30 Normal 180 Day Track
S160 1995-11-22 Special (immediate Track)
S159 1995-10-23 Normal 180 Day Track
S158 1995-09-25 Normal 180 Day Track
S157 1995-09-14 Normal 180 Day Track
S156 1995-08-24 Normal 180 Day Track
S155 1995-04-11 30-Day Supplement
S154 1995-03-09 Normal 180 Day Track
S153 1994-10-04 Normal 180 Day Track
S152 1994-07-05 Normal 180 Day Track
S151 1994-06-06 Normal 180 Day Track
S150 1994-05-24 Normal 180 Day Track
S149 1994-05-16 Normal 180 Day Track
S148 1994-04-26 Normal 180 Day Track
S147 1993-11-24 Normal 180 Day Track
S146 1993-10-12 Normal 180 Day Track
S145 1993-09-13 Normal 180 Day Track
S144 1993-08-12 Normal 180 Day Track
S143 1993-08-13 Normal 180 Day Track
S142 1993-07-23 Normal 180 Day Track
S141
S140 1993-06-16 Normal 180 Day Track
S139 1992-12-16 Normal 180 Day Track
S138 1992-12-16 Normal 180 Day Track
S137 1992-11-13 Normal 180 Day Track
S136 1992-11-02 Normal 180 Day Track
S135 1992-10-22 Normal 180 Day Track
S134 1992-09-03 Normal 180 Day Track
S133 1992-09-03 Normal 180 Day Track
S132 1992-08-27 Normal 180 Day Track
S131 1992-08-19 Normal 180 Day Track
S130 1992-08-10 Normal 180 Day Track
S129 1992-07-24 Normal 180 Day Track
S128
S127 1992-06-16 Normal 180 Day Track
S126 1992-06-09 Normal 180 Day Track
S125 1992-06-01 Normal 180 Day Track
S124 1992-04-23 Normal 180 Day Track
S123 1992-03-06 Normal 180 Day Track
S122 1992-03-05 Normal 180 Day Track
S121 1992-03-02 Normal 180 Day Track
S120
S119 1992-01-29 Normal 180 Day Track
S118 1991-12-23 Normal 180 Day Track
S117 1991-12-23 Normal 180 Day Track
S116 1991-12-20 Normal 180 Day Track
S115 1991-11-07 Special (immediate Track)
S114 1991-11-06 Normal 180 Day Track
S113 1991-10-18 Normal 180 Day Track
S112 1991-09-17 Normal 180 Day Track
S111 1991-09-19 Normal 180 Day Track
S110 1991-09-17 Normal 180 Day Track
S109 1991-08-08 Normal 180 Day Track
S108 1991-07-18 Normal 180 Day Track
S107 1991-07-17 Normal 180 Day Track
S106 1991-06-17 Normal 180 Day Track
S105 1991-06-12 Normal 180 Day Track
S104 1991-05-30 Normal 180 Day Track
S103 1991-05-23 Normal 180 Day Track
S102 1991-05-20 Normal 180 Day Track
S101 1990-10-19 Normal 180 Day Track
S100 1991-03-05 Normal 180 Day Track
S099 1991-01-07 Normal 180 Day Track
S098 1990-12-04 Normal 180 Day Track
S097 1990-11-21 Normal 180 Day Track
S096 1990-11-20 Normal 180 Day Track
S095 1990-11-13 Normal 180 Day Track
S094 1990-10-09 Normal 180 Day Track
S093 1990-10-02 Normal 180 Day Track
S092
S091 1990-09-21 Normal 180 Day Track
S090
S089 1990-06-15 Normal 180 Day Track
S088 1990-08-24 Normal 180 Day Track
S087 1990-08-20 Normal 180 Day Track
S086 1990-08-17 Normal 180 Day Track
S085 1990-08-17 Normal 180 Day Track
S084 1990-07-27 Normal 180 Day Track
S083 1990-07-10 Normal 180 Day Track
S082
S081 1990-07-05 Normal 180 Day Track
S080 1990-06-26 Normal 180 Day Track
S079 1990-06-26 Normal 180 Day Track
S078 1990-06-15 Normal 180 Day Track
S077 1990-06-15 Normal 180 Day Track
S076 1990-05-29 Normal 180 Day Track
S075 1990-05-25 Normal 180 Day Track
S074 1990-05-15 Special (immediate Track)
S073 1990-05-15 Normal 180 Day Track
S072 1990-05-03 Normal 180 Day Track
S071 1990-03-14 Normal 180 Day Track
S070 1990-01-22 Normal 180 Day Track
S069 1989-12-21 Normal 180 Day Track
S068 1989-12-21 Normal 180 Day Track
S067 1989-12-22 Normal 180 Day Track
S066 1989-10-31 Normal 180 Day Track
S065 1989-12-01 Normal 180 Day Track
S064 1989-09-29 Normal 180 Day Track
S063 1989-09-05 Normal 180 Day Track
S062 1989-08-08 Normal 180 Day Track
S061 1989-06-21 Normal 180 Day Track
S060 1989-06-21 Normal 180 Day Track
S059 1989-07-25 Normal 180 Day Track
S058 1989-07-24 Normal 180 Day Track
S057 1989-05-15 Normal 180 Day Track
S056
S055 1989-04-27 Normal 180 Day Track
S054 1989-02-02 Normal 180 Day Track
S053 1989-02-02 Normal 180 Day Track
S052 1988-11-18 Normal 180 Day Track
S051 1988-10-03 Normal 180 Day Track
S050 1988-09-26 Normal 180 Day Track
S049 1988-08-11 Normal 180 Day Track
S048 1988-05-06 Normal 180 Day Track
S047 1988-05-03 Panel Track
S046 1988-05-03 Normal 180 Day Track
S045 1988-04-01 Normal 180 Day Track
S044 1988-01-28 Normal 180 Day Track
S043 1988-01-26 Normal 180 Day Track
S042 1987-12-22 Special (immediate Track)
S041 1987-12-09 Normal 180 Day Track
S040 1987-10-26 Normal 180 Day Track
S039 1987-10-03 Normal 180 Day Track
S038 1987-09-08 Normal 180 Day Track
S037
S036 1987-07-31 Normal 180 Day Track
S035 1987-07-27 Normal 180 Day Track
S034 1987-06-19 Normal 180 Day Track
S033 1987-06-03 Normal 180 Day Track
S032 1987-05-26 Normal 180 Day Track
S031 1987-04-29 Normal 180 Day Track
S030
S029 1987-03-03 Normal 180 Day Track
S028
S027 1986-09-12 Normal 180 Day Track
S026 1986-08-04 Normal 180 Day Track
S025 1986-07-14 Normal 180 Day Track
S024 1986-06-11 Normal 180 Day Track
S023 1986-06-02 Normal 180 Day Track
S022
S021 1986-01-14
S020 1985-10-25
S019 1985-10-18
S018 1985-10-15
S017 1985-10-03
S016 1985-09-10
S015 1985-08-01
S014 1985-07-22
S013
S012 1984-12-19
S011 1984-04-27
S010 1984-01-19
S009 1983-11-14
S008 1983-06-21
S007 1983-06-07
S006 1983-05-31
S005
S004 1983-05-02
S003 1983-04-22
S002 1982-11-17
S001 1982-03-22
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