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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTHORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
Generic NameVentricular (assist) bypass
ApplicantAbbott Medical
6035 Stoneridge Drive
Pleasanton, CA 94588
PMA NumberP060040
Supplement NumberS005
Date Received04/20/2009
Decision Date01/20/2010
Product Code DSQ 
Docket Number 10M-0078
Notice Date 02/22/2010
Advisory Committee Cardiovascular
Clinical TrialsNCT00121485
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE THORATEC HEARTMATE II LVAS. THE 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. IT IS NOW ALSO INDICATED FOR USE IN PATIENTS WITH NEW YORK HEART ASSOCIATION (NYHA) CLASS IIIB OR IV END-STAGE LEFT VENTRICULAR FAILURE WHO HAVE RECEIVED OPTIMAL MEDICAL THERAPY FOR AT LEAST 45 OF THE LAST 60 DAYS, AND ARE NOT CANDIDATES FOR CARDIAC TRANSPLANTATION. 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
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