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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
Applicant
THORATEC CORP.
6035 stoneridge dr.
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 Product No
Recalls CDRH 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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 S017 
S018 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 S045 
S046 S047 S048 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 
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