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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.
 
DeviceTVL(TM) LEAD SYSTEM
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP950022
Date Received06/30/1995
Decision Date05/10/1996
Product Code LWS 
Docket Number 97M-0460
Notice Date 11/19/1997
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE VENTRITEX TVL LEAD SYSTEM:TRANSVENOUS RIGHT VENTRICULAR LEAD MODELS RV-1101, RV01, AND RV02; TRANSVENOUS SUPERIOR VENA CAVA LEAD MODELS, SV-1101, SV01, SV02, AND SV03; SUBCUTANEOUS LEAD MODELS, SQ-701 AND SQ01; VEIN PICK MODEL TV-0001; SILICONE LUBRICANT MODEL TV-0013; LEAD TUNNELER KIT MODEL LTK-01; MODEL AC-2481 HIGH VOLTAGE Y-ADAPTER; MODEL AC-CDT-EX VENTRITEX EXTERNAL STIMULATOR ADAPTER; AND TVL LEAD SYSTEM ACCESSORY KIT
Supplements: S077 S076 S002 S001  S063 S064 S074 S054 S032 S033 S034 
S035 S036 S037 S058 S078 S069 S089 S086 S031 S012 S019 S006 
S038 S039 S040 S072 S073 S018 S027 S028 S003 S004 S005 S052 
S053 S068 S041 S042 S043 S045 S046 S047 S048 S009 S010 S011 
S014 S017 S026 S091 S092 S096 S097 S099 S100 S101 S102 S103 
S104 S107 S108 S007 S008 S079 S080 S083 S084 S087 S090 S085 
S088 S081 S013 S015 S016 S020 S021 S022 S023 S024 S025 S030 
S050 S051 S055 S056 S057 S075 S060 S061 S062 S070 S071 S067 
S049 S105 S098 S095 S093 S106 S109 S110 S114 S115 S116 S117 
S118 S112 S135 S129 S132 S133 S138 S143 S142 S146 S147 S148 
S149 S145 S111 S120 S119 S113 S124 S125 S126 S137 S128 S134 
S136 S130 S131 S121 S122 S123 S139 S140 S141 S150 S144 S152 
S151 
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