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: TVL(TM) LEAD SYSTEM
• Generic Name: Implantable cardioverter defibrillator (non-CRT)
• Applicant: Abbott Medical; 15900 Valley View Court; Sylmar, CA 91335
• PMA Number: P950022
• Date Received: 06/30/1995
• Decision Date: 05/10/1996
• Product Code: LWS
• Docket Number: 97M-0460
• Notice Date: 11/19/1997
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No
• Recalls: CDRH 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: S078 S001 S085 S086 S089 S055 S056 S057 S058 S006 S068 ; S003 S013 S007 S008 S018 S002 S027 S028 S072 S073 S020 S021 ; S022 S023 S024 S025 S038 S039 S040 S012 S017 S047 S048 S049 ; S091 S092 S098 S105 S009 S010 S011 S004 S005 S076 S077 S079 ; S080 S087 S083 S084 S090 S081 S088 S015 S016 S041 S042 S043 ; S045 S046 S031 S032 S033 S050 S051 S060 S061 S062 S063 S064 ; S019 S054 S074 S014 S069 S034 S035 S036 S037 S026 S070 S071 ; S075 S030 S052 S053 S067 S095 S096 S107 S108 S109 S093 S099 ; S100 S101 S102 S103 S104 S097 S106 S112 S116 S117 S118 S132 ; S135 S138 S142 S137 S110 S114 S115 S113 S119 S111 S120 S124 ; S125 S126 S133 S134 S128 S129 S130 S131 S121 S122 S123 S143 ; S136 S139 S140 S141 S145 S144