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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameTHORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
Classification Nameventricular (assisst) bypass
ApplicantTHORATEC CORP.
PMA NumberP060040
Supplement NumberS005
Date Received04/21/2009
Decision Date01/20/2010
Product Code
DSQ[ Registered Establishments with DSQ ]
Docket Number 10M-0078
Notice Date 02/22/2010
Advisory Committee Cardiovascular
Clinical Trials NCT00121485
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
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