Premarket Approval (PMA)

Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.

• Trade Name: SYNCHRONY MODEL 2020T PULSE GENERATOR
• Classification Name: implantable pacemaker pulse-generator
• Generic Name: pulse generator
• Regulation Number: 870.3610
• Applicant: ST. JUDE MEDICAL, INC.
• PMA Number: P880086
• Date Received: 11/15/1988
• Decision Date: 08/21/1989
• Product Code: DXY [ Registered Establishments with DXY ]
• Docket Number: 89M-0363
• Notice Date: 09/13/1989
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No
• Supplements: S001 S002 S003 S004 S005 S006 ; S007 S008 S009 S010 S011 S012 ; S013 S014 S015 S016 S017 S018 ; S020 S021 S022 S023 S024 S025 ; S026 S027 S028 S029 S030 S031 ; S032 S033 S034 S035 S036 S037 ; S038 S039 S040 S041 S043 S045 ; S046 S047 S048 S049 S050 S051 ; S052 S053 S056 S060 S061 S062 ; S063 S064 S065 S066 S067 S068 ; S069 S070 S071 S072 S073 S075 ; S076 S077 S078 S079 S080 S081 ; S082 S083 S084 S085 S086 S087 ; S088 S089 S090 S091 S092 S093 ; S094 S095 S096 S097 S098 S099 ; S100 S101 S102 S103 S104 S105 ; S106 S108 S109 S110 S111 S112 ; S113 S114 S115 S116 S117 S118 ; S121 S122 S123 S124 S125 S126 ; S127 S128 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 S164 S165 S166 S167 S168 ; S169 S170 S171 S172 S173 S174 ; S175 S176 S177 S178 S180 S181 ; S182 S183 S184 S185 S186 S187 ; S188 S189 S190 S191 S192 S193 ; S194 S195 S196 S197 S198 S199 ; S201 S202 S203 S204 S205 S206 ; S207 S208 S209 S210 S211 S212 ; S213 S215 S216 S217 S218 S219 ; S221 S222 S223 S224 S225 S226 ; S227 S231 S232