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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 NameSTEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACING
Classification Namedrug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
Generic Nametransvenous pacing leads
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
PMA NumberP830061
Date Received10/03/1983
Decision Date07/29/1986
Product Code
NVN[ Registered Establishments with NVN ]
Docket Number 86M-0330
Notice Date 08/22/1986
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product Yes
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S017 S019 S021 
S022 S023 S024 S025 S026 S027 S028 S029 S030 
S031 S032 S033 S034 S035 S036 S037 S039 S040 
S041 S042 S044 S045 S046 S047 S048 S049 S050 
S051 S052 S053 S054 S055 S057 S058 S059 S060 
S061 S062 S063 S064 S065 S066 S067 S068 S069 
S070 S071 S072 S073 S074 S075 S076 S077 S078 
S079 S080 S081 S082 S083 S084 S085 S086 S087 
S088 S089 S091 S092 S093 S094 S096 S097 S098 
S099 S100 S101 S102 S104 S105 S106 S107 S108 
S109 S110 S111 S112 S113 S114 S115 S116 S117 
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