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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) CAPSUREFIX LEAD MODEL 4068,4067,4568
Classification Namedrug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
Generic Namepacing lead
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
PMA NumberP930039
Date Received11/01/1993
Decision Date03/29/1996
Product Code
NVN[ Registered Establishments with NVN ]
Docket Number 96M-0357
Notice Date 10/08/1996
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product Yes
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S022 S023 S024 S025 S026 S027 S029 S030 
S031 S032 S033 S034 S035 S036 S037 S039 S040 
S041 S042 S043 S045 S046 S047 S048 S049 S050 
S051 S052 S053 S055 S056 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 S087 S088 
S089 S090 S092 S093 S094 S095 S096 S097 S098 
S100 S101 S102 S103 S104 S105 S106 
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