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: TVL(TM) LEAD SYSTEM
• Classification Name: implantable cardioverter defibrillator (non-crt)
• Generic Name: transvenous defribilation lead system
• Applicant: ST. JUDE MEDICAL, INC.
• PMA Number: P950022
• Date Received: 06/30/1995
• Decision Date: 05/10/1996
• Product Code: LWS [ Registered Establishments with LWS ]
• Docket Number: 97M-0460
• Notice Date: 11/19/1997
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No

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.

Post-Approval Study

Show Report Schedule and Study Progress

• 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 S030 S031 ; S032 S033 S034 S035 S036 S037 ; S038 S039 S040 S041 S042 S043 ; S045 S046 S047 S048 S049 S050 ; S051 S052 S053 S054 S055 S056 ; S057 S058 S060 S061 S062 S063 ; S064 S067 S068 S069 S070 S071 ; S072 S073 S074 S075 S076 S077 ; S078 S079 S080 S081 S083 S084