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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 (LVAS)
Classification Nameventricular (assisst) bypass
ApplicantTHORATEC CORP.
PMA NumberP060040
Supplement NumberS038
Date Received01/13/2015
Decision Date02/12/2015
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for implementation of an additional existing electrical continuity test during the manufacturing process of the heartmate ii left ventricular assist system (lvas).
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