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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.
 
DeviceSCIMED PTCA DILATATION CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantSCIMED LIFE SYSTEMS, INC.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP860019
Date Received05/23/1986
Decision Date11/28/1986
Reclassified Date 10/08/2010
Product Code LOX 
Docket Number 86M-0496
Notice Date 01/16/1987
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 
S024 S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 
S037 S038 S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 
S050 S051 S052 S053 S054 S055 S056 S058 S059 S060 S061 S063 
S064 S065 S066 S067 S068 S069 S070 S071 S072 S073 S074 S075 
S076 S077 S079 S080 S081 S082 S083 S084 S085 S086 S087 S088 
S089 S090 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 S120 S121 S122 S123 S124 S125 
S126 S128 S129 S130 S131 S132 S133 S134 S135 S136 S137 S138 
S140 S141 S142 S143 S144 S145 S146 S147 S149 S150 S151 S152 
S153 S154 S155 S156 S157 S158 S159 S160 S161 S162 S163 S164 
S166 S167 S168 S169 S170 S171 S172 S173 S174 S175 S176 S177 
S178 S179 S180 S181 S182 S183 S184 S185 S186 S187 S188 S189 
S190 S191 S192 S194 S195 S196 S197 S198 S199 S200 S201 S202 
S203 S205 S206 S207 S208 S209 S210 S211 S212 S213 S214 S215 
S216 S217 S219 S220 S221 S222 S223 S224 S225 S226 S227 S228 
S229 S230 S231 S232 S233 S234 S235 S236 S237 S238 S240 S241 
S242 S243 S244 S245 S246 S247 S248 S249 S250 S251 S252 S253 
S255 S256 S258 S259 S260 S261 S263 S264 
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