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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceATTAIN STARFIX MODEL 4195 LEAD
Generic NameDrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP060039
Date Received12/27/2006
Decision Date06/13/2008
Product Code OJX 
Docket Number 08M-0478
Notice Date 08/27/2008
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE ATTAIN STARFIX MODEL 4195 LEAD. THE ATTAIN STARFIX MODEL 4195 STEROID ELUTING, TRANSVENOUS LEAD WITH DEPLOYABLE LOBE FIXATION IS INTENDED FOR CHRONIC PACING AND SENSING OF THE LEFT VENTRICLE VIA THE CARDIAC VEIN, WHEN USED IN CONJUNCTION WITH A COMPATIBLE IMPLANTABLE PULSE GENERATOR OR IMPLANTABLE CARDIAC DEFIBRILLATOR.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S028 S029 S030 S031 S032  S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S018 S019 
S020 S021 S022 S023 S024 S025 S026 S027 S033 S034 S035 S036 
S037 S038 S039 S040 S041 S042 S043 S044 S046 S047 S049 S050 
S051 S052 S053 S054 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 S086 
S087 S088 S089 S090 S091 S092 S093 S094 S095 S096 S097 S098 
S099 S100 S101 S102 S103 S104 S105 S106 S107 S108 S109 S110 
S111 S112 S113 S114 S115 
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