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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 NameATTAIN STARFIX MODEL 4195 LEAD
Classification Namedrug eluting permanent left ventricular (lv) pacemaker electrode
Applicant MEDTRONIC INC.
PMA NumberP060039
Date Received12/27/2006
Decision Date06/13/2008
Product Code
OJX[ Registered Establishments with OJX ]
Docket Number 08M-0478
Notice Date 08/27/2008
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
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 S018 S019 
S020 S021 S022 S023 S024 S025 S026 S027 S028 
S029 S030 S031 S032 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 
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