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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceSIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantADVANCED CARDIOVASCULAR SYSTEMS, INC.
26531 YNEZ RD.
TEMECULA, CA 92591
PMA NumberP810046
Date Received09/11/1981
Decision Date03/03/1982
Reclassified Date 10/08/2010
Product Code LOX 
Docket Number 82M-0071
Notice Date 03/26/1982
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Supplements: S001 S002 S003 S004 S006 S007 S008 S009 S010 S011 S012 S014 
S015 S016 S017 S018 S019 S020 S021 S023 S024 S025 S026 S027 
S029 S031 S032 S033 S034 S035 S036 S038 S039 S040 S041 S042 
S043 S044 S045 S046 S047 S048 S049 S050 S051 S052 S053 S054 
S055 S057 S058 S059 S060 S061 S062 S063 S064 S065 S066 S067 
S068 S069 S070 S071 S072 S073 S074 S075 S076 S077 S078 S079 
S080 S081 S083 S084 S085 S086 S087 S088 S089 S091 S093 S094 
S095 S096 S097 S098 S099 S100 S101 S102 S103 S104 S105 S106 
S107 S108 S109 S110 S111 S112 S113 S114 S115 S116 S117 S118 
S119 S121 S122 S123 S124 S125 S126 S127 S129 S130 S131 S132 
S133 S134 S135 S136 S137 S138 S139 S140 S141 S142 S143 S144 
S145 S146 S147 S148 S149 S150 S151 S152 S153  S154 S155 
S156 S157 S158 S159 S160 S161 S162 S163 S165 S166 S167 S168 
S169 S170 S171 S172 S173 S174 S175 S176 S177 S179 S180 S181 
S182 S183 S185 S186 S187 S188 S189 S190 S192 S193 S194 S195 
S196 S197 S198 S199 S200 S201 S202 S203 S204 S205 S206 S207 
S208 S209 S210 S211 S212 S213 S214 S215 S216 S217 S218 S219 
S220 S221 S222 S223 S224 S225 S226 S227 S228 S229 S230 S231 
S232 S234 S236 S237 S238 S240 
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