Premarket Approval (PMA)

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.

• Device: VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATOR
• Generic Name: Implantable cardioverter defibrillator (non-CRT)
• Applicant: BOSTON SCIENTIFIC; 4100 Hamline Avenue North; St. Paul, MN 55112
• PMA Number: P910077
• Date Received: 12/23/1991
• Decision Date: 06/17/1994
• Product Code: LWS
• Docket Number: 94M-0241
• Notice Date: 08/15/1994
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No
• Recalls: CDRH Recalls
• Supplements: S056 S057 S083 S036 S024 S025 S066 S067 S029 S030 S031 S032 ; S108 S109 S040 S105 S075 S038 S039 S052 S058 S059 S060 S061 ; S062 S063 S076 S077 S078 S079 S080 S081 S045 S092 S093 S094 ; S095 S021 S022 S084 S086 S098 S068 S071 S072 S073 S074 S087 ; S088 S089 S100 S101 S090 S091 S106 S107 S103 S104 S166 S186 ; S162 S178 S179 S160 S161 S152 S158 S155 S156 S153 S102 S033 ; S035 S037 S097 S026 S027 S110 S111 S112 S113 S115 S116 S117 ; S118 S119 S120 S121 S122 S123 S141 S142 S143 S144 S145 S146 ; S147 S148 S149 S150 S151 S096 S047 S048 S049 S050 S051 S023 ; S041 S042 S043 S044 S188 S189 S001 S002 S004 S006 S007 S008 ; S009 S010 S124 S125 S126 S127 S128 S129 S130 S131 S132 S133 ; S134 S135 S136 S137 S138 S139 S011 S012 S014 S015 S016 S018 ; S019 S020 S140 S184 S053 S054 S055 S046 S154 S157 S159 ; S167 S163 S180 S181 S174 S175 S192 S194 S193 S164 S165 S169 ; S170 S173 S168 S176 S177 S171 S172 S183 S190 S182 S185 S187 ; S191