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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.
 
DeviceTHORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
Generic NameVentricular (assist) bypass
ApplicantAbbott Medical
6035 Stoneridge Drive
Pleasanton, CA 94588
PMA NumberP060040
Date Received12/22/2006
Decision Date04/21/2008
Product Code DSQ 
Docket Number 08M-0283
Notice Date 05/07/2008
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE THORATEC HEARTMATE II LVAS. THIS DEVICE IS INDICATED FOR USE AS A BRIDGE TO TRANSPLANTATION IN CARDIAC TRANSPLANT CANDIDATES AT RISK OF IMMINENT DEATH FROM NON-REVERSIBLE LEFT VENTRICULAR FAILURE. THE HEARTMATE II LVAS IS INTENDED FOR USE BOTH INSIDE AND OUTSIDE THE HOSPITAL, OR FOR TRANSPORTATION OF VENTRICULAR ASSIST DEVICE PATIENTS VIA GROUND AMBULANCE, FIXED-WING AIRCRAFT, OR HELICOPTER.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S007 S008 S009 S061 S062 S063 S010 S072 S073 S052 S053 
S014 S015 S016 S017 S018 S020 S021 S022 S023 S024 S031 S032 
S033 S034 S035 S036 S037 S038 S039 S040 S041 S042 S043 S044 
S045 S046 S047 S048 S049 S050 S051 S054 S055 S056 S057 S058 
 S066 S025 S026 S027 S028 S029 S030 S006 S059 S005 S060 
S064 S065 S011 S012 S013 S002 S003 S004 S076 S085 S091 S092 
S106 S107 S108 S110 S111 S100 S101 S102 S103 S068 S069 S070 
S067 S074 S075 S078 S077 S071 S080 S081 S087 S079 S088 S089 
S090 S082 S083 S086 S115 S116 S117 S097 S098 S099 S105 S109 
S104 S113 S114 S118 S119 S093 S094 S095 S096 
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