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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 NameCAPSURE SP, CAPSURE, CAPSURE 2 LEADS, EXCELLENCE S, IMPULSE, IMPLUSE II EXCELLENCE SS, LEADS
Classification Namedrug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
Generic Nametranvenous atrail & ventricular pacing leads
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
PMA NumberP850089
Date Received12/17/1985
Decision Date07/29/1986
Product Code
NVN[ Registered Establishments with NVN ]
Docket Number 86M-0329
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 S016 S017 S018 
S020 S023 S024 S026 S027 S028 S029 S030 S031 
S032 S033 S034 S035 S036 S037 S038 S039 S040 
S041 S042 S043 S044 S045 S046 S047 S049 S050 
S051 S052 S053 S054 S055 S056 S057 S058 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 S090 S091 S092 S093 S094 S095 S097 
S098 S099 S100 S101 S102 S103 S104 S105 S106 
S107 S108 S109 S110 S111 S112 
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