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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
Recalls CDRH Recalls
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 
S108 S109 S111 S113 S114 S116 S117 S118 S119 
S120 S121 S122 S123 S124 S125 S126 S127 S128 
S129 S131 S132 S133 S134 S135 S136 S137 S138 
S139 S140 
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