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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameMEDTRONIC(R) TRANSVENE LEAD SYSTEM
Classification Namepermanent defibrillator electrodes
Generic Namepacer cardioverter defibrillator
Applicant MEDTRONIC INC.
PMA NumberP920015
Date Received04/01/1992
Decision Date12/09/1993
Product Code
NVY[ Registered Establishments with NVY ]
Docket Number 94M-0063
Notice Date 04/19/1994
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination Product Yes
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S020 
S021 S022 S023 S024 S025 S027 
S028 S029 S030 S031 S032 S035 
S036 S037 S038 S039 S040 S041 
S042 S043 S044 S045 S046 S047 
S049 S050 S051 S052 S053 S054 
S055 S056 S057 S058 S059 S061 
S062 S063 S064 S065 S067 S068 
S069 S070 S071 S072 S073 S074 
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 S107 
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